Colorado Life Science Deal Flow

We’ve Moved! Come Visit Us at the New URL!

2009-10-18T21:22:00.004-07:00

This is the final post for Colorado Life Science Deal Flow (http://rnaventures.blogspot.com). We have packed up and moved to the new and improved Life Science Deal Flow site (http://LifeScienceDealFlow.com). If you have not yet clicked on over to the new site then you are missing out on the wine and cheese being served. While visiting the Life Science Deal Flow site be certain to renew your subscription – simply click on your preferred mode of delivery, i.e. email or RSS. For those of you selecting email delivery, be certain to look for the separate subscription activation email (it may have gone to the junk mail folder if it is not in your in box) and click on the link to activate.

We certainly hope you enjoy the broadened content offering at LifeScienceDealFlow.com. Please send any press releases, hot-tips, questions and comments to arubenstein@rnaventures.com.

My back is aching from all of the moving but I believe you will enjoy all of the moist and chewy early-stage life science company goodness being served up at Life Science Deal Flow – it’s not just a new coat of paint…

Colorado Life Science Deal Flow is signing off…in 3…2…1…

Memories,
Like the corners of my mind
Misty water-colored memories
Of the way we were
Scattered pictures,
Of the smiles we left behind
Smiles we gave to one another
For the way we were
Can it be that it was all so simple then?
Or has time re-written every line?
If we had the chance to do it all again
Tell me, would we? could we?
Memries, may be beautiful and yet
Whats too painful to remember
We simply choose to forget
So its the laughter
We will remember
Whenever we remember...
The way we were...
The way we were...

Under Construction | CLSDF to the All New LSDF!

2009-10-12T06:26:00.005-07:00

Good morning. Please note blog coverage this week of 12 October will be spotty as a result of new changes being implemented, particularly:

1) The evolution of [Colorado] Life Science Deal Flow (version 1.0 currently located at the url http://rnaventures.blogspot.com) is progressing to the new Life Science Deal Flow blog (version 2.0 located at the url http://CLSDF.com). Note: the previous url redirect from CLSDF.com to rnaventures.blogspot.com has now been officially terminated.

2) A new “look and feel” is being deployed, to include logo modifications, a new cool color palete, and an improved and easy to navigate site layout, etc.

3) New advertising options will become available that combine with the Life Science Deal Flow sister site http://OnBioVC.com to provide unique and targeted combined advertising campaigns that leverage i. site-based (LSDF & OnBioVC) ii. subscription-based (email and RSS) and iii. print-based (Monthly OnBioVC Trend Analysis reports) exposure. (contact me arubenstein@rnaventures.com for more information), and finally…

4) If you are asking yourself “why this, why now?” Well...perhaps you have too much free time on your hand however, this catalyst for change, specifically the broadening of content covered from Colorado-specific entities to more national and international in scope is a result of both the maturation of the ecosystem and indication from folks of a high interest in an expansion of the content funnel.

Certainly we understand some faithful readers may be lost as a result of the new Life Science Deal Flow orientation (we have appreciated your steadfast patronage over the years). For those focused solely on Colorado life science content I encourage you to follow the coverage provided by our friends at Rocky Radar. To those of you who continue on this new evolutionary branch with us, first allow me to thank you for your loyalty, support and inspiration, and please be aware that a slight modification to your email and/or RSS feed will be requested (directions will be provided) when we return to the air. As always please forward tips, requests, questions and comments to me at arubenstein@rnaventures.com.

Please Stay Tuned! We Will Return to the Air Shortly!

Omeros | Lackluster IPO Debut a Good Sign?

2009-10-09T06:38:00.004-07:00

Omeros (NASDAQ: OMER) launched itself onto the Nasdaq global marketplace yesterday with its initial public offering of 6.82M shrs priced at $10 raising approximately $68M less underwriting expenses. Its foray however, was more dud then thud relative to its peers in the Biopharma IPO Class of 2009. For Omeros is the only clinical-stage, pre-commercial, pre-revenue entity to get out and it would appear that the market is not going to reward entities at this stage of development as demonstrated by an immediate sell-off of some nearly 20% before clawing back a bit on this first day of trading to close at $8.73 per share.

This debut provides a very interesting piece of data, though with an N=1 it is hardly statistically significant, nevertheless let’s try and make this “empirical” statement – Pick your analogy, the biopharma public markets are thawing, the biopharma public markets window is opening etc., what is now been demonstrated is that the IPO route for pre-clinical biopharma is less liquidity opportunity for early investors and more financing event to capitalize operations.

Therefore a takeaway here may be to expect big pharma M&A to remain hyper-active for the foreseeable future. Though such a collection of trends may not be ideal for life science entities as options and leverage arms may be limited it is however, a sign that as the public markets claw and scratch their way back that newly positively trading companies are theoretically higher quality going concerns that are being demanded by the street; a clear message that irrational exuberance is no longer accepted…at least in the life science healthcare sector.

AGA Medical Holdings | Back in the Queue

2009-10-08T07:15:00.007-07:00

AGA Medical (Plymouth, MN) developer of interventional devices for the minimally invasive treatment of structural heart defects and peripheral vascular disorders, first filed with the intention to reach the public market in 2008 (‘nuff said), now on the heels of what is shaping up to be, dare one say, an active 2H09 life science IPO market with three entities out [Mead Johnson Nutrition (NYSE: MJN), Cumberland Pharma (NASDAQ: CPIX) and Talecris (NASDAQ: TLCR)] and now three in the filed queue planning to get out prior to year’s end. As the first snowfall is expected today in Boulder, CO it is feeling uncharacteristically warm and fuzzy inside – can ‘it’ thaw concurrent with old man winter settling in?

The AGA deal again makes sense, that is generally speaking…a pattern is emerging where these entities who have surfaced on the public markets are commercial-stage, certainly not pre-clinical or early-clinical but Phase IIb or later. It sounds as if AGA had revenue circa 2008 in the $180M range with a positive net income to boot. The offering is expected to be priced in the $19 to $21 range on 13.75M shares therefore raising an anticipated $260M to $289M less underwriter expenses. The deal is expected to be managed by Bank of America (NYSE: BAC), Citigroup (NYSE: C), Deutsche Bank (NYSE: DB), Leernik Swann, Wells Fargo (NYSE: WFC) and Natixis Bleichroeder.

Founded in 1995 by Dr. Kurt Amplatz, a former University of Minnesota professor and researcher, AGA Medical’s range of Amplatzer® products help improve patient outcomes, reduce length of hospital stay and accelerate patient recovery times. Amplatzer® products advanced the treatment of the most common congenital “holes in the heart,” such as atrial septal defects, patent foramen ovale and ventricular septal defects. More than 1,500 articles supporting the benefits of Amplatzer® products have been published. AGA Medical markets Amplatzer® products in 101 countries worldwide.

Note: According to the [C]LSDF 2009 Biopharma IPO Watch List confidence in the new issues appears to be maintained as the bottom has not dropped out post issuance; an additional encouraging sign of the receptivity of the markets.

Allos | Get it When You Can...

2009-10-07T07:08:00.004-07:00

Many a seasoned and sophisticated biopharma executive have described to me the reality of when an entity does not need to raise capital it should because at some point it will be needed, and by not needing it, the situation may, just may…lend itself to perhaps lowering the cost of capital due in part to the leverage of not exactly needing it at the time of the raise (Wow, that was a mouthful). Now that Allos Therapeutics (NASDAQ: ALTH) has hung out their ‘open for business’ sign with the recent approval of Folotyn™ for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma is additional capital required? Well building a commercial enterprise may take upwards of $10 to $20M, there are now scaled manufacturing needs and let us also consider the broad ongoing clinical pursuits for follow-on indications of Folotyn™. No doubt, all capital intensive pursuits.

A quick scan of the most recent balance sheet for Allos indicates cash and cash equivalents plus short term investments totaling approximately $105M, certainly that has evaporated throughout the second quarter at a burn rate of perhaps $14.1M (cash from operations plus cap ex), leaving a guesstimated cash position at around $80 - $90M today? Not exactly an uncomfortable place to be sitting. So what is one to do sitting in this seemingly well capitalized position? Correct! Go out and raise more money! And that is exactly what the plan is.

Allos has announced the price of a new public offering of 14,000,000 shrs of common stock set at $7.10 yielding a planned gross proceeds of $99.4M, expected to close on 13 October. Allos has also granted the underwriters a 30-day option to purchase up to an aggregate of 2,100,000 additional shares of common stock to cover over-allotments, if any. The deals’ underwriters include J.P. Morgan Securities, Citigroup Global Markets, Leerink Swann, JMP Securities, Needham & Company, and RBC Capital Markets.

Get it when you can…

Inviragen | Series A $15M and M&A

2009-10-07T06:11:00.005-07:00

Inviragen (Ft. Collins, CO) a preclinical-stage vaccine company focused on emerging global infectious diseases, closed a $15M Series A financing and in the process merged the assets of Singapore-based SingVax. Participants in the round include Charter Life Sciences, Venture Investors, Bio*One Capital and Phillip Private Equity. This initial round of institutional capital comes on the heels of a $600,000 grant, announced in September, from the National Institute of Allergy and Infectious Disease to partially support continued development of a dengue vaccine.

The new funding is expected to push a number of vaccine candidates into the clinic and yield proof-of-concept and efficacy data. The lead vax is designed to protect against dengue fever, a mosquito-borne disease that threatens 3.6 billion people living in tropical and subtropical regions around the globe; 36 million cases of dengue fever are thought to occur per year WW, the most severe form of the disease, dengue hemorrhagic fever, leads to the deaths of approximately 20,000 people annually.

Rounding out the robust Inviragen pipeline include vaccines against Hand, Foot and Mouth disease, Japanese encephalitis, West Nile, chikungunya, avian- (H5N1) and swine-origin (H1N1) influenza and, a combination plague and smallpox vaccine for biodefense.

GlobeImmune | Presenting Phase II Data @ AASLD

2009-10-06T07:10:00.004-07:00

GlobeImmune (Louisville, CO) a clinical-stage company focused on developing targeted immunogens for the treatment of cancer and infectious diseases, has had an abstract (“GI-5005 Therapeutic Vaccine Plus PEG-IFN/Ribavirin Improves End of Treatment Response at 48 Weeks Versus PEG-IFN/Ribavirin in Naïve Genotype 1 Chronic HCV Patients”) for their investigational hepatitis C virus product candidate accepted for presentation at the 60th Annual Meeting of the American Association for the Study of Liver Diseases (31 Oct. to 4 Nov. 2009 Boston, MA).

GlobeImmune will also present at AASLD end-of-treatment, 48-week data in interferon-naïve patients from a Phase II clinical study investigating the efficacy and safety of GI-5005 plus peg-interferon (peg- IFN) and ribavirin, the current standard of care, in patients with genotype 1 chronic HCV infection compared to patients receiving only SOC.

Chronic hepatitis C infection, a viral liver disease, is a major health epidemic worldwide. Currently, there are approximately 170 million people worldwide who are infected with the hepatitis C virus. Of these, 4 million live in the United States with an additional 5 million in Western Europe. Approximately 20-30% of all hepatitis C patients will face life threatening complications as a result of their disease. Hepatitis C accounts for 20% of cases of acute hepatitis, 70% of cases of chronic hepatitis, 40% of cases of end-stage cirrhosis, 60% of cases of hepatocellular carcinoma and 30% of liver transplants in the United States. The incidence of new symptomatic infections of hepatitis C has been estimated to be 13 cases/100,000 persons annually. For every one person who is infected with the AIDS virus, there are more than four infected with hepatitis C. The Centers for Disease Control and Prevention estimate that there are up to 230,000 new hepatitis C infections in the U.S. every year. Currently, 8,000 to 10,000 deaths each year are attributed to hepatitis C.

The GI-5005 Tarmogen expresses a fusion protein encompassing sequences from both HCV NS3 and Core proteins. NS3 and Core are abundantly expressed in infected cells, are required for viral replication and contain targets that are recognized by both CD4+ "helper" and CD8+ "killer" T cells. Both the Core and NS3 proteins are highly conserved among HCV genotypes 1a and 1b, the HCV strains most prevalent in the U.S. In December 2007, GI-5005 initiated a multi-center, randomized, Phase 2 study in combination with standard of care (pegylated interferon plus ribavirin).

Biodesix | First Tranche of $10M Series B

2009-10-06T06:41:00.005-07:00

Biodesix (Broomfiled, CO) a commercial-stage molecular diagnostics company focused on proteomic-based diagnostics, closed the first tranche of a $10M Series B financing. The company is enabling personalized health care via their mass spectrometry-based molecular profiling proprietary platform technology, ProTS®, to discover and validate diagnostic tests for the improvement of patient outcomes.

Biodesix' first product, VeriStrat®, a pretreatment serum proteomic test for patients with advanced non-small cell lung cancer is now commercially available for physicians to help guide their treatment of patients (view the demo [HERE]). The test identifies patients who are likely to have good or poor outcomes after treatment with EGFR-TKIs. Samples are processed in Biodesix' CLIA accredited laboratory and results are typically reported within 72 hours of sample shipment. VeriStrat® has been validated in clinical studies with over 1000 patients, and the Company is engaging in additional studies to further validate the test and to explore the clinical utility of VeriStrat® in other solid epithelial tumors and with other EGFR inhibitors.

October | Breast Cancer Awareness Month

2009-10-04T11:10:00.009-07:00

In recognition of October as Breast Cancer Awareness Month [C]LSDF is highlighting a few of the early-stage entities who are on the front-line in the battle against breast cancer that have been recently funded and are offering interesting scientific approaches in an effort to yield novel potential treatments, diagnostics and cures.

If you are interested in providing your individual support please visit the Susan G. Komen Search for the Cure™ info and donation page [HERE].

Aragon Pharmaceuticals based in San Diego, CA, is a discovery-stage small molecule company focused on therapeutics for the treatment of hormone-resistant cancers, with an initial focus on prostate and breast cancer.
Quantum Immunologics based in Tampa, FL is a clinical-stage biopharmaceutical company focused on breast cancer.
Alethia Biotherapeutics based in Montréal, Québec is a development-stage biotechnology company focused therapeutic monoclonal antibodies for the treatment and prevention of severe bone loss, ovarian cancer, and metastatic breast cancer.
Micrima based in Bristol, England is an early-stage stage company focused on radio wave technology to improve detection of breast cancer.
Cianna Medica based in Aliso Viejo, CA is a brachytherapy medical device company focused on women’s health and dedicated to the innovative treatment of early-stage breast.
Sanarus Medical based in Pleasanton, CA provides minimally invasive products for the diagnosis and treatment of breast tumors.
Sopherion Therapeutics based in Princeton, NJ is a late-stage oncology company with a potential first-line therapy in combination with cyclophosphamide for patients with metastatic breast cancer.

Talecris | And Then There Were Three!

2009-10-01T19:06:00.006-07:00

Part of the [C]LSDF ongoing series Watching the Bio IPO Market.

Talecris Biotherapeutics (NASDAQ: TLCR) made a thunderous debut with its Initial Public Offering on the Nasdaq today, offering 50,000,000 shares at $19 and raising $950M in the process. The fun however, did not stop there as the third life science offering of the year powered through the remainder of day, ringing the closing bell at $21.15, or a market cap of ~$1.06B! Speaking of ringing the bell, look for Talecris CEO Larry Stern to ring the opening bell at the Nasdaq on Friday morning (2 October 2009).

According to the [C]LSDF IPO Watch List the three companies to get out this year have raised in aggregate ~$1.85B, what is of particular interest is how they have responded by the very least maintaining or bettering their opening valuation (see price chart below).

What I find to be of particular interest in the case of Talecris is the story behind the story – or more specifically, the early investors who were handsomely rewarded by the street today. Just to put this tale into context Talecris is a robust entity, 2008 financials indicate revenue of $1.4B and a net income of $66M and thus account for (IMHO) the makings of a completely legitimate offering from a (potential) going-concern perspective.

Back in 2005 private equity (then) behemoth Cerberus Capital Management and Ampersand Ventures acquired from Bayer (XETRA: BAY.DE) their Talecris (then NPS Biotherapeutics) franchise for $590M, as part of a reorg effort. In the interim Cerberus placed some massive bets on Chrylser, who filed for bankruptcy protection and GMAC, who found themselves in need of a government bailout to the tune of $5B. Needless to say Cerberus was taking their lumps and the limited partners were clamoring for a return of their capital therefore, a liquidity opportunity for Talecris was paramount; the first shot came via a planned IPO circa 2007 but as the public markets then turned to ice the filing was killed; strike one. The next effort came back in August of 2008 when a potential monster $3.1B deal for Talecris was placed on the table by Australian blood plasma company CSL, this deal however fell apart primarily due to antitrust concerns. So in 2009 third-times-a-charm and Talecris finally gets out, in a still challenging environment.

What does this IPO mean to Cerberus? Well, various sources have reported that the fund owned 74% of Talecris prior to the IPO and retained approximately 38% post IPO, based on day 1’s closing price that values their piece of the action in the ballpark of $400M but don’t feel too bad for Cerberus as it appears as though over $800M in dividends were distributed in 2005-06. So all in maybe a return of $1.2B, call it maybe 2.5-3X. It is being widely reported that Cerberus was all in for less than $100M and therefore returns of 20-25X are being touted – I can’t quite get my head wrapped around that math and the distributions from a percent ownership perspective. If you know better than [C]LSDF, and that is probably most folks, will you please provide some insight? Or if there are any super-motivated MBA students out there I’m certain this would make for a fascinating case study. One thing I do know for certain is that the life science IPO market will remain an interesting place to observe.

Tape-Delay from the RMLSIC | That’s a Wrap!

2009-10-01T06:55:00.005-07:00

The Rocky Mountain Life Science Investor Conference yielded a sense of sophistication and intensity catalyzed by the aggregation of high-quality presenting companies and top-tier venture and corporate investors. I was hardly surprised that then rumor, hearsay and innuendo combined to yield quite a bit of buzz throughout the oak paneled hallways of the Ritz Carlton about “interest”, “follow-on meetings”, and yes even “term sheets” and “syndicated deals”. Perhaps the most important take-away for this author is the continued realization that location in the obvious clusters is not a prerequisite for funding, rather great science and IP, great management and great market opportunity are the combined elements that often create opportunity for an entity when it goes shopping for an institutional round of financing.

We have previously covered the presenting companies:

Part I – The Diagnostic companies [HERE]
Part II – The Biopharma companies [HERE]
Part III – The Medical Device companies [HERE]

Here then is a list of those participating venture and corporate investors:

Venture Capital Funds

Corporate Investors

Amgen (NASDAQ: AMGN)
Celgene (NASDAQ: CELG)
Covidien (NYSE: COV)
Genentech (NYSE: DNA)
Johnson & Johnson (NYSE: JNJ)
Eli Lilly (NYSE: LLY)
NovaQuest [Quintiles]

And to those individuals, associations and entities who made it all possible, a collective thank you and see you at the 2010 Rocky Mountain Life Science Investor Conference!

Sponsors
AZBio, Bowne & Co. (NYSE: BNE), Capital Advisors Group, Colorado Bioscience Association, Forest City Science + Technology Group, Cooley Godward Kronsih, Doresy & Whitney, Ernst & Young, Fitzsimons Redevelopment Authority, High Country Venture, inVentiv Clinical, Johnson & Johnson, Johnson & Johnson Development Corp., Montana Biosience Alliance, Morgenthaler Ventures, NMBio, Oklahoma Bioscience Association, PhRMA, Rocky Mountain Venture Capital Association, Sequel Venture Partners, Silicon Valley Bank, TriNet, Ubiquity, Utah Office of Economic Development and vSpring Capital.

Looking for Some of This?

2009-09-30T06:54:00.004-07:00

[Update | Add Domain Associates, Domain Partners, VIII $500M to the early-stage drug and device sectors; bringing recently closed funds up to $1,925M]

Recently Boston, MA-based Excel Venture Management announced the close of the new $125M Excel Medical Fund. The portfolio is a planned balance across healthcare IT and services, diagnostics, and medical devices, plus life science platforms that address adjacent markets which may include energy, chemicals, defense and agriculture. It is made unambiguously clear that single molecule drug companies need not apply – for such an approach is not of interest to their principals. Initial investments are in the $1M to $5M range and it appears at least five investments have been made to date, these include 1. Aileron Therapeutics (who is developing Stapled Peptides, an entirely new therapeutic modality that can target all human diseases) 2. BioTrove (who provides micro- and nano-scale technologies to the research and diagnostics markets) 3. Dormir (an integrated provider of sleep diagnostic services, therapy and equipment) 4. MedVentive (provider of healthcare IT business intelligence solutions) and 5. Synthetic Genomics (who is designing metabolic pathways for the production of biochemicals and next generation biofuels from a variety of feedstocks).

Additional life science funds that have closed within the last twelve months include Essex Woodlands Ventures $900M Fund VIII which invests across the spectrum of drug, device and service companies in North America, Europe and Asia, and Morgenthaler Ventures checked in with their $400M Fund IX, who in their press release indicated a continued focus on early-stage investing.

So sum it all up and approximately $1,425M in new early-stage life science capital is needing to be put to work and eventually returned at some hopeful market exceeding multiple to the fund's limited and managing partners. What are you doing to make your entity “investable”?

OnBioVC | July '09 Trend Analysis Available

2009-09-28T19:52:00.005-07:00

Hot off the press! (and, better late than never…) The July 2009 OnBioVC | Trend Analysis study is now available for FREE via download [HERE]. Over $668M flowed into early-stage biopharma, diagnostic and device companies in the seventh month of 2009 and over $3,821M year-to-date! Find out who is investing in what and where.

Word on the street is that money is sitting on the sideline, not willing to be put to work in early-stage life science companies. A quick sort of the July data at OnBioVC.com shows that perhaps such a thesis is not on point; why in 31 days observed were 8 Series A financings raising $59.7M, or 1 in 5 deals were done as an entities first institutional round, throw in the B’s and we are talking 54% of July deals accounting for $326.4M.

A little trick for leveraging the data found at OnBioVC; say you are a pre-clinical oncology company looking to identify potential investors…simply go to the drop-down box on OnBioVC.com, select “X-Oncology”, observe the list of “Series A” financings then wa-la, you will find in each post all of the participating investors and hyperlinks to their sites. If you have any questions or problems on how to effectively mine the data at OnBioVC shoot me an email at arubenstein@rnaventures.com. Wishing you statistically significant data!

Allos THx | Significant Milestone Achieved!!!

2009-09-27T21:09:00.010-07:00

Now, some 48-hours later, it may be considered old news that Allos Therapeutics (NASDAQ: ALTH) received from FDA accelerated approval for Folotyn™ (pralatrexate) for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma (PTCL). Folotyn™ is the first and only drug approved by FDA for PTCL and represents a new treatment option for patients with relapsed or refractory PTCL. Allos anticipates entering the market with Folotyn™ in the US in October. The sound of champagne corks popping can be heard echoing up and down the Front Range as the Colorado life science ecosystem celebrates this significant and important milestone and simultaneously breaths a collective sigh of relief.

Let’s then take a bit of a closer look at Allos, their approved product, market and pipeline, shall we? (As always…if there is any erroneous data or statements identified and requiring correction please leave a comment below or email arubenstein@rnaventures.com and we will update with or without (your choice) attribution).

Hematological malignancies account for approximately 15% of all cancers and are categorized into four groups, 1. Multiple Myeloma, 2. Myelodysplastic Syndromes, 3. Leukemia – which includes acute myeloid, acute lymphoblastic, chronic myeloid, and chronic lymphocytic leukemia, and 4. Lymphoma – which is divided into Hodgkin’s and non-Hodgkin lymphoma. NHL is further grouped into:

Cutaneous T-cell lymphoma
Follicular lymphoma
Mantle cell lymphoma
Diffuse large B-cell lymphoma, and
Peripheral T-cell lymphoma

According to the American Cancer Society, non-Hodgkin lymphoma incidence has grown 3.8% from 2005 to 2009. The US PTCL market is growing at an estimated incidence rate of 5% due, in part, to increased PTCL awareness; the addressable market is approximately 80-90% of estimated first-line patients treated (according to Allos), or more specifically of ~6,800 patients forecasted in 2013, ~6,200 are treatable. It has been reported that single agent treatments prescribed off label for PTCL average approximately $76,000 per patient per therapeutic and therefore one may calc the total addressable market at ~$516M to $471M per year – NOTE: this is not a market forecast for Folotyn™.

Allos maintains exclusive worldwide commercial rights to Folotyn™ for all indications and their exists the potential for co-promotion or out-licensing to reach EX-US markets. The composition of matter patent protection is in place till 2017 in the US and EU with the potential for an additional 5-year extension under Hatch-Waxman. Additional potential hematological malignancy indications for Folotyn™ that are under clinical investigation include B-cell non-Hodgkin’s lymphoma, non-Hodgkin’s lymphoma and cutaneous T-cell lymphoma, and in solid tumor indications for bladder cancer and non-small cell lung cancer.

Folotyn™, a next generation chemotherapy, is a rationally designed, for improved cancer cell uptake and retention, anti-folate. The mechanism of action of Folotyn™ is a folate analog that inhibits folate metabolism by binding to and inhibiting the enzyme DHFR. Folotyn™ has high affinity for the RFC-1 protein and is an efficient substrate for polyglutamation by the enzyme FPGS. Polyglutamated Folotyn™ has a prolonged intracellular half-life, which allows for prolonged action in malignant cells. The relative increase in cellular uptake by RFC-1 and differences in polyglutamate formation may account for the enhanced activity of Folotyn™.

Some additional players in the hematological malignancy market include Biogen Idec (NASDAQ: BIIB) who markets with Roche (VTX: ROG.VX) Rituxan® for non-Hodgkin’s lymphoma; Novartis (NYSE: NVS) who markets Gleevec® for chronic myeloid leukemia, and; Wyeth (Pfizer) (NYSE: WYE) who markets Mylotarq® for acute myeloid leukemia.

It will be fascinating to observe Allos evolve from a development-stage company to a commercial-stage entity. Needless to say this is an incredible achievement – bringing a new treatment option to market for patients with relapsed or refractory PTCL.

FDA Allos pic courtesy of http://topnews.us

Tape-Delay from the RMLSIC | 3 of 4

2009-09-24T22:25:00.007-07:00

Today’s third of four installments covering the Rocky Mountain Life Science Investor Conference focuses on the medical device presenting companies. In addition, here are some links to the additional coverage:

Part I – The Dx companies [HERE]
Part II – The Biopharma companies [HERE]
Part iV – Summary [In the Works]

BiOptix – Boulder, CO-based BO has developed a highly sensitive biosensor for real-time detection of trace amounts (~pg/mm^2) of bacteria, viruses, proteins, miRNA and other nucleic acids, and antibodies. The patented biosensor design relies upon common path interferometric detection in combination with non-resonant surface Plasmon excitation – the design of which was conceived by University Colorado 2005 Physics Nobel Prize Laureate and BO Chief Scientific Advisor John Hall.

Coherex – Salt Lake City, UT-based commercial-stage CH is focused on catheter-based technologies for the treatment of certain structural heart defects. The initial focus is on a minimally invasive device to treat a common defect called Patent Foramen Ovale (PFO). The FlatStent™ PFO Closure System includes an implantable, self-expanding Nitinol stent with a polymer substrate designed to stimulate tissue growth within the PFO. AN exclusive multi-year distribution agreement with Abott Laboratories (NYSE: ABT) was recently announced.

Kinetic Muscles – Tempe, AZ-based KM is a preclinical-stage medical tehnology company focusing on recovery for victims of stroke, traumatic brain injury and other neurological injury via the combination of robotic therapy technology and telemedicine to create a ‘virtual clinic’ that delivers therapy to the patients home. The company recently signed a supplier contract with Healthsouth (NYSE: HLS), the largest provider of rehabilitation services in the US.

Leap Frogg – Grand Junction, CO-based LF is a clinical-stage company developing the Frogg Dynamic Compression System, a venous augmentation system for the prevention of deep vein thrombosis prevention, pulmonary embolus prevention and edema therapy.

Medipacs – Tuscon, AZ-based MP is developing the Mini-Infuser™ a disposable infusion pump drug delivery system whose pumps utilize a polymer actuator that enables precise programmed delivery. The technology lowers manufacturing costs and enables the creation of small infusion devices that may be worn by patients.

Medivance – Louisville, CO-based MV is a commercial-stage company focused on the Actic Sun™ product, a therapeutic temperature management designed to improve patient outcomes through precise control of core body temperature after traumatic events such as cardiac arrest, traumatic brain injury and hemorrhagic stroke.

Micro-Imaging Solutions – Greenwood Village, CO-based MIS has developed a technology enabling miniaturization of CMOS disposable micro-digital cameras that are low cost, high resolution and enable extreme product design flexibility in a variety of medical device applications that do or may not have previously incorporated imaging.

Numira Biosciences – Salt Lake City, UT-based NB is a specialty Contract Research Organization focusing on Virtual Histology™, a new technology for soft tissue nas skeletal imaging combining proprietary contrast agents and software with microCT imaging; and, high performance visual analytics via the graphic processing unit for accelerated image processing and analysis techniques.

Regenesis Biomedical – Scottsdale, AZ-based RB is a commercial-stage company marketing the Provant Therapy System® which delivers Cell Proliferation Induction® therapy into post-operative skin tissues to reduce pain and edema in the inflammatory phase of wound healing via triggering mitosis and gene expression of various growth factors, extracellular matrix proteins and enzymes involved in tissue repair and regenerations.

ThermImage – Salt Lake City, UT-based TI is a preclinical-stage company developing Thermaflux Scan™ for the safe and noninvasive detection of pediatric Vesicoureteral Reflux, a common and under-diagnosed condition where urine flows back to the kidneys from the bladder, exposing them to infection.

Valve Xchange – Aurora, CO-based VX is a preclinical-stage company developing the Vitality™ Exchangeable Heart Valve for adult and pediatric/congenital heart valve disease – an permanently implanted docking station and exchangeable leaflet set, when needed, using minimally invasive techniques – offering a lifetimes tissue valve alternative to mainstream heart valve patients.

Vital Access – Salt Lake City, UT-based VA a developmental-stage company focused on Vital Access Venous Window™ a fully-interventional vessel anastomosis device enabling interventionalists to percutaneously create anastomoses (connecting two different vessels) without using sutures or the need for invasive surgery. The Venous Window™ may provide quicker, easier and more reliable cannulation access to hemodialysis patient’s fistula while also potentially improving fistula longevity and patient quality of life.

Snoasis Medical | Born to Smile!

2009-09-23T15:48:00.009-07:00

Commercial-stage Snoasis Medical (Denver, CO) is focused on the development and commercialization of products which redefine the way clinicians perform perioplastic surgery. The core technology behind Snoasis Medical’s current product offering is placental tissue. These placental tissue products are believed to be the first of its kind for dental applications and possess features and benefits which may lead to improved satisfaction for the patient and the clinician. BioCover™, the initial Snoasis product to reach the market, represents possibly the first allograft composed of amnion tissue for use as a wound covering for the treatment of gingival recession.

This novel solution to gingival recession is a processed, dehydrated graft containing multiple layers of human amnion tissue. BioCover™ technology leverages the basement membrane architecture of oral mucosal tissue and the high concentration of the adhesion factor, laminin-5. The product does not require hydration prior to use – it rehydrates upon placement and naturally self-adheres to the exposed root surface and proximal bone, this unique attribute eliminates the need to suture the graft into place – and therefore BioCover™ may become the preferred procedure to the current standard-of-care where patient tissue is first harvested from the palate and then sutured in place.

Greg Gumbel, host of the business news program, The Economic Report takes his camera and staff on a journey exploring the large market of gingival recession, or receding gum lines, (>25% of US adults, Company data) and details how and why the BioCover™ solution brought to market by Snoasis Medical is positioned to potentially transform the use of amniotic tissue and the incorporation of regenerative medicine in the dentistry market. Watch the video below, or if reading this via email or RSS-reader click [HERE] to view. Finally read the coverage of Snoasis Medical in the July 2009 issue of Orthopedics This Week [HERE].

The Program You Are Watching is a Paid Advertisement for Snoasis Medical

Anthera | Working to Thaw the Markets

2009-09-22T22:48:00.003-07:00

CLSDF continues to maintain keen watch on the thawing of the public equity markets, calibrated in a semi-quantitative approach via the life science IPO pricings. If all three of the current filings get out priced ‘as-is’ I would then call the score FINANCING EVENT 3 & LIQUIDITY OPPORTUNITY 2. A nice balance and it makes sense as the three clinical-stage pre-revenue companies (Cumberland, Omeros and Anthera) appear to intend to use the public offering as a capital source to finance the phase III to commercialization processes.

Anthera Pharmaceuticals is the newest name to be added to the CLSDF-IPO Watch List. Hayward, CA-based Anthera Pharmaceuticals is a privately-held company committed to developing and commercializing clinical pharmaceutical products that address unmet medical needs of patients with life-threatening, chronic and acute inflammatory diseases and autoimmune disorders. The Company has acquired from Eli Lilly (NYSE: LLY) and Shionogi & Co. worldwide rights (excluding Japan) to a series of clinical and pre-clinical compounds that inhibit the enzymatic activity of members of the phospholipase family - a group of enzymes responsible for the release of arachidonic acid and subsequent production of leukotrienes‚ prostacyclins and other mediators of inflammation. These highly potent compounds inhibit novel‚ upstream steps in the inflammation cascade and have the potential to address a variety of diseases.

Tape-Delay from the RMLSIC | Part Deux

2009-09-21T19:55:00.008-07:00

Continuing here with Part Deux of the Rocky Mountain Life Science Investor Conference presenting companies. Yesterday CLSDF posted the Diagnostic oriented entities, today we feature the biopharma folks.

ApopLogic – Aurora, CO-based AL is a biopharmaceutical company focused on the discovery, and development of therapeutic products that target apoptotic cell death pathways found in cancers, leukemias and lymphomas. The lead compound is Breceptin, a novel anti-cancer technology that antagonizes neuropeptide growth-factor receptors, targeting a broad range of cancers. The pipeline also includes Fasaret a proprietary therapy based on Fas ligand, an apoptotic cell death-inducing molecule with unique pro- inflammatory properties and Cytonil a proprietary combination of a cell-type specific growth factor and a cell signaling agonist to treat Sezary leukemia, cutaneous T cell lymphoma and psoriasis.

Allogenesis – Denver, CO-based AG is focused on pHPM, a ‘humanized’ purification of blood extracts for expansion of stem cells used for research & clinical applicications as well as wound healing in the dermal, orthopedic and additional soft tissue applications. The pHPM product is engineered to replace animal proteins in stem cell culture applications and augment existing in vitro culture media.

BioAmps – Aurora, CO-based BA is focused on focused on the discovery and development of proprietary antimicrobial peptide therapeutic solutions for the treatment of systemic infectious diseases, including methicillin-resistant Staphylococcus aureus (MRSA) and other resistant gram-negative and gram-positive bacteria. A rational design platform has produced a large portfolio of D-confirmation, alpha-helical antimocrobial peptides that are structurally manipulated to alter their hydrophobicity and amphipathicity properties. The charge substitutions and structure alterations on both the polar and non-polar faces of the peptides produce a unique “carpeted model” mechanism of action, broad spectrum of activity, and low level of toxicity to human cells.

GlobeImmune – Louisville, CO-based GI develops active immunotherapies called Tarmogens® for the treatment of cancer and infectious diseases. Tarmogens are recombinant yeast engineered to express disease antigens. Lead products include GI4000 and GI5005 both in Phase II for cancer and hepatitis C. The Tarmogen™ manufacturing process is simple and scalable with small molecule-like margins.

Inviragen – Ft. Collins, CO-based IV is focused on vaccines against emerging worldwide infectious diseases. Compounds queued up for clinical trials includes DENVax against dengue, HFMDVax against hand, foot and mouth disease and JEVax for Japanese encephalitis. In addition, are a number of ongoing vaccine research programs in chikungunya, HPV, influenza and plague vaccines.

LigoCyte Pharmaceuticals – Bozeman, MT-based LCP is a clinical-stage biologic drug development company focused on respiratory and gastrointestinal indications. The company’s virus-like particle (VLP) vaccine technologies support products that induce robust immune responses to prevent serious infections. The lead product is Norovirus VLP Vax in Phase I and the pipeline includes the biodefense vaccines against influenza and anthrax and the monoclonal antibodies Anti-CD103 partnered with Biogen Idec (NASDAQ: BIIB) and Anti-CD62 partnered with NIH.

miRagen – Boulder, CO-based MR is developing innovative microRNA (miRNA) based therapeutics for cardiovascular and muscle disease. The lead optimization pre-clinical pipeline candidates are focused on heart failure with indications of post-MI remodeling, chronic heart failure and refractory angina; broader cardiovascular disease including cardiac fibrosis, angioplasty/restenosis and arrhythmia; and, general fibrosis, muscular atrophy and amyotrophic lateral sclerosis.

Myocept – Lafayette, CO-based MC is a pre-clinical stage biopharmaceutical company focused on biotherapeutics designed to modulate signal transduction through subtypes of the cholinergic receptor family (AChR). The receptors targeted control contraction of skeletal and smooth muscle fibers, while other members of the AChR family are involved in angiogenesis, pain, additiction, down-regulation of inflammatory immune responses and progression of certain cancers.

Western States Biopharma – Aurora, CO-based WSB is a pre-clinical stage biopharmaceutical company developing novel therapies that selectively modulate adaptive immunity to treat inflammatory diseases while concurrently affecting the immune system’s natural ability to fight disease. Potential lead indications under consideration for WSBI19711A include rheumatoid arthritis, psoriasis, psoriatic arthritis, ulcerative colitis, and anklyosing spondylitis.

FDA 2.0…Really?

2009-09-21T19:49:00.003-07:00

Now this is interesting! The Food and Drug Administration's Center for Drug Evaluation and Research, in collaboration with FDA's Center for Biologics Evaluation and Research , Center for Veterinary Medicine, and Center for Devices and Radiological Health, has announced a public hearing (scheduled for 12 & 13 November in Washington DC) to discuss issues related to the promotion of FDA-regulated medical products (including prescription drugs for humans and animals, prescription biologics, and medical devices) using the Internet and social media tools (can you say Twitter, Facebook, YouTube and the blogosphere, etc.?). FDA is seeking participation in the public hearing and written comments from all interested parties, including, but not limited to, consumers, patients, caregivers, health care professionals, patient groups, Internet vendors, advertising agencies, and the regulated industry. This meeting and the written comments are intended to help guide FDA in making policy decisions on the promotion of human and animal prescription drugs and biologics and medical devices using the Internet and social media tools. FDA is seeking input on a number of specific questions but is interested in any other pertinent information participants in the hearing would like to share. From my understanding the last discourse FDA held on the matter was in October of 1996. For a blast from the (Web 1.0) past to a look at the transcript [HERE].

Tape-Delay from the RMLSIC | Part I

2009-09-20T20:26:00.005-07:00

I had the best intentions of bringing up to the minute information flowing through CLSDF from the content rich Rocky Mountain Life Science Investor Conference however, during the first company presentation slot it quickly became apparent that due to the richness of the subject matter in order to keep up I had to turn off the laptop and turn on my brain. So with that said here is an overview recap of the presenting entities broken out by biopharma, device and diagnostic companies. So without further adieu here are the Dx entities who presented:

Applied Microarrays – In 2007 Tempe, AZ-based AM acquired the microarray assets of GE Healthcare (NYSE: GE); the core technology capabilities include design and production of DNA and protein microarrays, circulating tumor cell capture microarrays and, expertise in surface chemistries, capture probe design, precision piezoelectric printing, assay optimization and reagent formulation.

Axial Biotech – Salt Lake City, UT-based AB ScolioScore™ AIS prognostic test is the first molecular Dx DNA-based assay for spinal disorders. The prognostic is a clinically validated test with a 99% negative predictive value that determines the likelihood of severe spine curve progression for children diagnosed with Adolescent Idiopathic Scoliosis. The product is being marketed by DePuy Spine, a Johnson & Johnson (NYSE: JNJ) company.

Beacon Biotechnology – Aurora, CO-based BB BrightSPOT System™ point-of-care diagnostic microarray chip enables up to 100 simultaneous diagnostic assays to be performed simultaneously with a single blood or other fluid sample. The handheld reader instrument moves the laboratory to the bedside. Initial therapeutic foci is on infectious diseases and diabetes.

Biodesix – Broomfield, CO-based BD is a developer of Dx tests using their proprietary platform based upon mass spectrometry. The company is advancing the revolution in personalized medicine, providing physicians with clinical information that assists with the diagnosis of disease and selecting appropriate and effective therapeutic treatments. The first product, VeriStrat®, a simple blood test used by oncologists to assist in decision making while treating non-small cell lung cancer, was marketed in 2008.

Castle Biosciences – Friendswood, TX-based CB is a biomarker-based oncology multivariate molecular Dx company focusing on orphan cancers. Their first product, DecisionDx-GBM, was taken to market in 1Q09 and targets glioblastoma multiforme, the most common form of primary brain cancer. The DecisionDx-LEA product is currently in clinical development.

High Throughput Genomics – Tuscon, AZ-based HTG is a commercial stage diagnostic company offering the quantitative Nuclease Protection Assay (qNPA™) Gene Expression Platform, a multiplexed, lysis-only assay of mRNA and miRNA with no RNA extraction, no labeling and no amplification required.

LineaGen – Salt Lake City, UT-based LG is target validation stage specialty Dx company offering tests for Autism, Osteoporosis, COPD and Multiple Sclerosis that leverage its access to the biomarker discovery research platform provided by the Utah Genetic Research Project and the Utah Population Database.

nanoMR – Albuquerque, NM-based NMR is developing a Dx for the detection and identification of bacteria and fungi in blood, the primary cause of sepsis. The assay, promising results in as little as one hour uses immune-labeling to attach magnetic beads to the blood borne pathogens that are then detected via nuclear magnetic resonance imaging.

EJ BioMed in Bed with Stryker

2009-09-20T18:25:00.002-07:00

EJ BioMed, a spin-off from Ft. Collins, CO-based Eldon James Corporation, who focuses on production of critical use components for medical devices, recently announced an exclusive supplier deal with Stryker (NYSE: SYK) to design and produce tubing and fittings for next-gen Stryker Medical hospital mattresses. The new 105-pod cushion matrix mattress was developed to prevent pressure ulcers by incorporating a unique technology to eliminate the need for repeatedly turning patients.

Live Blogging from the RMLSIC

2009-09-16T20:41:00.012-07:00

UPDATE (Breakfast) - Roy Davis, VP Corporate Development at Johnson & Johnson (NYSE: JNJ) and President JNJ Development Corporation opened the first full day of the RMLIC. He focused on “Creating New Business Opportunities at Johnson & Johnson” and stressed how a targeted focus on fostering innovation outside the entity (in addition to internal development) is in place which may ultimately benefit JNJ. Highlighting current P&L and capital stresses faced by the earliest start-up to the behemoth large-cap big pharma and associated headwinds in the current economic climate have increased the challenge to manage business for the long term. Red Script Ventures was founded by JNJ Dev Corp in part to help address the challenges of making the leap from not the incremental technological progression but to larger replacement technological leaps. Historically JNJ would participate in investing at the B round or later. Today Red Scrip Ventures participates in early-stage equity investing and provides value-add business acceleration and incubation services via leveraging access to the significant resources available throughout the entire JNJ enterprise. One caveat, and an obviously understandable one, Red Script must be the only strategic investor participating in a particular deal. Off to the first round of presentations…I’ve selected the Dx track.

Laptop…check, wifi…check, Conference pass…check! CLSDF is primed to live blog the 2009 Rocky Mountain Life Science Investor Conference coming to you from the Ritz-Carlton Denver in the Mile High City. Check back throughout the day for updates, likewise I’ve embedded my twitter-feed below, as certain ‘tweets’ may be more timely and serve as a good backup if the wifi is disrupted (or follow along at http://twitter.com/arubenstein). Note that I will be updating the embedded picture album below throughout the day as well. If you are reading this post in an email or RSS feed be certain to visit http://CLSDF.com to observe the updates.

The Conference got off to a delightful start at the Governor’s Residence at Boettcher Mansion, well technically our group was directed to the on premises ‘Carriage House’, simply lovely nonetheless. A few opening remarks by CBSA President John Collar before hearing a brief history of the Colorado life science ecosystem from Morgenthaler Ventures Partner Chris Christoffersen. Then it was off to the Cotes du Rhone, delectable tapas and some serious elbow rubbing.

Next up i. breakfast speaker and ii. the first group of presenting companies. Stay tuned…

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1 IPO! 2 IPO?? 3 IPO???

2009-09-16T07:21:00.005-07:00

UPDATE: Lots can happen between an early morning blog post and the end of the business day. In this case Omeros has set its IPO terms; 6.82M common shares offered between $10 and $12 per share. So the company is hoping to raise between $68.2 and $81.8M. The planned ticker to trade under is NASDAQ: OMER. Bring on the opening bell!

First Fed Chairman Bernanke says that the worst recession since the Great Depression is seemingly behind us, then my home re-appraises for 30K higher than what was hoped and prayed for, and now…all sorts of activity in the life science IPO market. What is going on here? Have we hit bottom? A quick scan to my right of the early CNBC coverage and I see that the market is up +31 at the open, green, green, green everywhere I look. Really? Hmmm…well ever the optimist, I too am swinging from Bear to Bull and in fact would like to go out on a limb here and have CLSDF call Tuesday 16 September 2009 as the bottom.

The public life science markets have been en fuego the last few months; just take a look at the NASDAQ Biotech Index (below) and similarly the 2Q09 OnBioVC Trend Analysis [HERE] shows similar positive investment growth in the private life science companies.

Last month Nashville, TN-based Cumberland Pharmaceuticals (NASDAQ: CPIX) went public raising $85M @ $17 per share and was essentially the first IPO in about two years sans the Bristol-Meyers Squibb (NASDAQ: BMY) spin-off of the Mead Johnson Nutrition (NYSE: MJN) unit. Since its debut Cumberland has more or less maintained its strength and avoided a major sell-off, at last check it is trading at $15.40. And just last week Cumberland launched their fever and pain drug Caldolor®, an injectable form of ibuprofen intended for patients who are hospitalized and cannot take oral drugs.

Now with Cumberland a public entity and certainly enjoying the time, effort and expense of remaining a public going-concern here comes the flood of filings behind them. Well OK, perhaps just a trickle, but the trickle may be the preface to the flood.

Filing paperwork with the Securities and Exchange Commission is the Seattle-based biotech Omeros, a clinical-stage company whose most advanced product candidate is OMS103HP, designed to improve postoperative joint function and reduce pain following arthroscopic anterior cruciate ligament reconstruction surgery. Currently in Phase III an NDA filing is expected to be submitted to FDA in 2H10. The planned offering would be underwritten by Deutsche Bank Securities, Wedbush Pacific Growth Life Sciences, Leerink Swann, and Needham & Company, according to the filing.

Similarly Research Triangle Park, NC-based Talecris has also filed paperwork with the SEC regulatory agency. With more than 4,500 employees and annual revenues north of $1.4B a Talecris IPO is certain to dwarf what happened with Cumberland and Omeros, if they can get out, being a pre-revenue entity. It would not be surprising to see upwards of $1B raised on this offering. Talecris is marketing Gaumnex® for immune therapy deficiencies, Prolastin® for alpha1-antitrypsin deficiency and Koate-DVI® for hemophilia.

Clearly there is a buzz of activity transpiring in the space. Where will you be positioned when the flood gates open?

Checking in with Juvaris Biotherapeutics

2009-09-15T07:42:00.003-07:00

Recall that Steven Dow, DVM, Ph.D., Professor in the departments of Clinical Sciences and Pathology in the College of Veterinary Medicine at Colorado State University, co-founded Juvaris Biotherapeutics.

Good or bad, Juvaris is now a Burlingame, CA-based biotechnology company, developing adjuvanted vaccines for infectious diseases. Recently a definitive agreement with Antigen Discovery, Inc. was announced providing Juvaris access to ADi's proprietary high-throughput protein microarray screening system to discover novel disease-specific antigens. Juvaris will sponsor research for multiple disease targets and pay ADi upfront payments, development milestones and royalties on licensed products in exchange for full product development rights to all fields except diagnostics, which will belong to ADi.

This deal comes on the heels of reporting results demonstrating that their universal influenza vaccine produces robust antibody responses and complete protection in H1N1 and H3N2 pre-clinical challenge models. Juvaris’ universal influenza vaccine has demonstrated significant induction of immunity with a novel construct of M2e, which is a conserved sequence found on all influenza A strains. The Juvaris universal flu vaccine is composed of conserved antigenic epitopes for both influenza A and B strains combined with its proprietary adjuvant, JVRS-100. The objective of the universal influenza vaccine is to improve the reliability and quality of protection by raising cross-protective immunity to all strains of influenza.

In clinic the JVRS-100 vax appears promising as well… In a Phase I study, 128 young adult subjects in groups of 20-24 were vaccinated with a licensed trivalent influenza vaccine with or without JVRS-100. Subjects receiving JVRS-100 adjuvanted vaccine were shown to have antibody responses to influenza A that were approximately two-fold higher than recipients of unadjuvanted vaccine. The adjuvant was well tolerated, and the incidence of adverse events following vaccination with JVRS-100 at effective dose levels was similar to that in the vaccine-alone groups.

The future appears encouraging for Juvaris, with a deal with Bayer Animal Health on the books and a diverse opportunity in seasonal, pandemic and universal influenzas, and herpes simplex virus-2, look for the company to close a new round of funding soon, possibly led by Kleiner Perkins again, to be reported at OnBioVC.

The Term Sheet | ‘Don’t Miss’ Seminars

2009-09-13T22:17:00.007-07:00

There are a couple of upcoming seminars that are architected to yield some sophisticated insight on typically complex issues around financing early-stage life science companies. The first event courtesy of the Colorado Bioscience Association is Negotiating the Venture Term Sheet (25 September 9am, @ Cooley Godward – to RSVP or for more info click [HERE]). This will be a mock role-play term sheet negotiation providing perspective from both sides of the table as well as some tips on how to resolve impasses. The second event courtesy of the Society of Physician Entrepreneurs and Holland & Hart is Fundraising and Securities Law (14 October 7:30am, @ Bioscience Park Center – to RSVP or for more info contact Molly Edwards meedwards@hollandhart.com). This seminar is focused on understanding securities laws related to fundraising from an angel investor (not VC/PE/IB) perspective (qualified accredited investors).

Aggregated below are some insights on common terms within the term sheet provided courtesy of local Boulder VC Brad Feld. Though Brad is focused on IT investing naturally there is plenty ‘o relevant overlap on the life science entity term sheets. This content should provide you with a solid foundation and load you up with relevant questions to bring to the seminars.

Keep in mind however how asymmetric views may be brought forth by all of these resources. I would love to use Colorado Life Science Deal Flow to facilitate a deeper conversation focused on fundraising, including Angel/VC/PE/IB/etc. So if you have thoughts and/or experiences to share please leave a comment at the bottom of this post at http://CLSDF.com or email me and indicate whether or not you would like your comments published in follow-on posts.

Finally, you may wish to bookmark this particular post so that the following terms discussions are easily referenced.

Term Sheet | Price
Term Sheet | Liquidation Preference
Term Sheet | Board of Directors
Term Sheet | Protective Provisions
Term Sheet | Drag Along
Term Sheet | Anti-Dilution
Term Sheet | Pay to Play
Term Sheet | Dividends
Term Sheet | Redemption Rights
Term Sheet | Conversion
Term Sheet | Conditions Precedent to Financing
Term Sheet | Vesting
Term Sheet | Information and Registration Rights
Term Sheet | Right of First Refusal
Term Sheet | Voting Rights and Employee Pool
Term Sheet | Restriction on Sales and Proprietary Info
Term Sheet | Founders Activities
Term Sheet | Initial Public Offering Shares Purchase
Term Sheet | No Shop Agreement
Term Sheet | Indemnification and Assignment
Term Sheet | Compelled Sale Right

Tom Cech | On CNBC Squawk Box

2009-09-11T07:39:00.005-07:00

Tom Cech recently appeared on the CNBC pre-market morning program Squawk Box to discuss a variety of topics including the future of biomedical research, the Colorado Initiative in Molecular Biotechnology and the 1989 Nobel Laureate’s return to the University of Colorado where he will also be resuming teaching freshman chemistry.

It is always fascinating to listen to Dr. Cech but what made this particular interview so special was the combination of not only who was answering the questions but who was asking the questions, that was CNBC Squawk Box anchor and University of Colorado, Molecular, Cellular and Developmental Biology graduate Joe Kernen. After Joe graduated CU MCDB he went on to graduate school at the Massachusetts Institute of Technology where his work focused on erythroleukemia cells, and led to publications in CELL, Developmental Biology, and Cold Spring Harbor Symposia on Quantitative Biology, and then focused his career on Wall St.

The eight minute interview is embedded below. If you are reading this post via an email or RSS subscription please click [HERE] to watch the video at http://CLSDF.com.

SharesPost | Private Company Transactions

2009-09-10T10:10:00.003-07:00

In the spirit of cool…I stumbled upon SharesPost – a sort of CraigsList meets ebay for buyers and sellers of private company equity. Talk about creating a new marketplace. Naturally there is a lot of legalese required to complete such a transaction, from investor qualification to transact, to escrow and indemnification agreements and beyond. Now I’m no attorney, nor do I play one in the blogosphere but it does appear, to my naive eye, that SharesPost does yeomen’s work to address all of the requisite issues in and around private placements. In addition to the marketplace platform is some very robust company research that is often challenging to come by, particularly for privately held entities.

Though the SharesPost market is not surprisingly weighted towards technology companies there are some biotechs listed including a few molecular diagnostics companies, Navigenics and XDx, and Greystone Pharmaceuticals. You can see price-per-share offers on both the buy and sell side along with implied valuations for each offering, now that is cool. And the coolness does not stop there – research analyst opinions provide estimated target prices too. I would be a bit careful here however with these reports and valuations, though they do contain relationship disclosures there are often mountains of material facts that are not accessible.

But hey…if someday you may think, geez…I sure wish I could have bought some shares of Facebook or LinkedIn before they went public, well...now you can – and it will cost you $14.75 and $11.25 per share respectively.

All material contained herein is for informational purposes only and should not be construed as an offer or solicitation of an offer to buy or sell securities.

CIMB-Caruthers Groundbreaking | 9 Sept

2009-09-08T21:02:00.002-07:00

Some of you may have had your head buried in a text book, an .xls file or bent over the lab bench with pipette in hand (or more likely...all three) and therefore have not heard about the Colorado Initiative in Molecular Biotechnology yet. CIMB’s mission is to foster new research, teaching, and technology development at the interface of life sciences, physical sciences, mathematics, computational sciences, and engineering. The focus of this initiative is to understand and manipulate living cells and control cellular behavior through a global analysis of molecular events using methods that span a continuum from basic to applied research. The area referred to as "molecular biotechnology" includes new methods in genomics, proteomics, molecular and cellular imaging, biophysics, mathematical analysis, materials engineering and chemical synthesis, which are leading the way towards fundamental changes in experimental sciences.

On Wednesday 9 September at 4:15pm Colorado Governor Bill Ritter, University of Colorado President Bruce Benson, Nobel Laureate and CU Distinguished Professor Tom Cech, CU-Boulder Chancellor Philip DiStefano and members from the entire CU-Boulder community will gather on the CU-Boulder East Campus to celebrate the groundbreaking of the Jennie Smoly Caruthers Biotechnology Building, the new home to CIMB. Come be a part of this wonderful celebration and Colorado life science milestone.

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Back-to-School BioBeers!

2009-09-08T20:43:00.003-07:00

It’s Back-to-School & Back-to-Denver for BioBeers. We hope the summer was a fruitful time for you. Needless to say we are excited to kick-off ( yet) another exciting season of BioBeers, coming to you from live from high above the Mile High City – 27 floors high to be exact – at the swanky Peaks Lounge in the Hyatt Regency – Denver.

Equally as exciting will be the preface to BioBeers,that is the first annual Rocky Mountain Life Science Investor Conference! The Conference features investors from San Fran to Boston and presenting companies not only from here in Colorado (like…Beacon Biotechnology, Biodesix, BiOptix, GlobeImmune, MyoCept and ValveXchange, to name a few) but also from Arizona, New Mexico, Utah and Montana (like…Axial Biotech, Castle Biosciences, LigoCyte Pharmaceuticals, Medipacs, NanoMR and Numira Biosciences, to name a few).

We would also like to extend a warm welcome to all of our guests from out of town to come join us at BioBeers and unwind after what is certain to be an exciting, though long, day of presentations and partnering meetings. Peaks Lounge is a delightful 7 short block walk from the Ritz Carleton. Hope to see you there!

Be certain to follow BioBeers on Twitter | @BioBeers

When: September, 17th @ 6:30pm
Where: Peaks Lounge @ Hyatt Regency Denver, 27th Floor (650 15th St.)

Mark your calendars and please be certain to RSVP at http://BioBeers.com for the 17 September event.

BioBeers: Connecting Bio-Entrepreneurs Since 2007

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Venrock | Building Companies for 40 years

2009-09-01T08:56:00.002-07:00

The history of Venture Capital dates back to 1946 courtesy of the American Research and Development Corp., founded by Georges Doriot, who is subsequently considered to be the father of VC. Though many may argue the following (myself included)…The birth of biotechnology can be pegged to the 1953 presentation of the DNA double-helix structure by Watson and Crick (and others). So then one may postulate that these two industries, VC & biotech, have more or less grown-up together. Talk about symbiosis…survival of each seemingly dependent upon the other (that is when considering life science specific venture funds).

One fund in particular has been masterfully catalyzing biotechnologies now for some forty-years…Venrock, who to date has invested approximately $2.4 billion in 437 companies since fund inception yielding and incredible 124 IPO's and 129 M&A exits. Simply an amazing track record! Some of these companies include Geron (Nasdaq: GERN), Gilead Sciences (Nasdaq: GILD), Idexx Labs (Nasdaq: IDXX), Ligand Pharma (Nasdaq: LGND), Millenium Pharma (Nasdaq: MLNM) and Sepracor (Nasdaq: SEPR) just to name a few.

In celebration of their rich (pun intended…) history and 40-year milestone Venrock has published Shaping the Future: 40 Years of Innovation. If you have an entrepreneurial streak in you set aside some time to enjoy the following focus on 40 start-ups (bio and non-bio) and the entrepreneurs that created them. (If you have trouble observing the slide presentation in your CLSDF email subscription take a look [HERE]).

Venrock: Shaping the Future, 40 Years of Innovation

View more documents from Dev Khare.

The Best $200 You Can Spend on 9/17!

2009-08-31T08:14:00.006-07:00

If you have not heard about the upcoming Rocky Mountain Life Science Investor Conference at the Ritz Carlton – Denver on 17 September, yet, you sure will get an earful about it here at CLSDF.

Today’s post particularly applies to those companies who have applied to present at the RMLSIC and were not selected as well as those entities who have not applied (perhaps you thought you were not ready to present yet?). Knowing that capital raising in our world is essentially, well…essential, the perspective of institutional life science investors is key in helping to highlight and address the critical “commercially relevant” questions that an early-stage entity must focus upon in order to efficiently leverage finite resources.

Denver will play host to 16 (at least) funds at the RMLSIC. By spending $200, for entities spun-out of universities (or $500 for companies without university affiliations) you can sign up for the RMLSIC BioPartnering Program – the program goal is to provide an opportunity to meet one-on-one with investors who are (believe it or not…) very interested to hear, comment and perhaps criticize what you have cooking in the lab. These VC’s are keenly aware of how “early” your entity is, and they are more than OK with that because there is an opportunity to help suggest a commercial trajectory – after all though the experiments you are planning for or running might make for a cool paper in Nature they very likely may not yield the data that can lead to a partnering deal with big pharma or a Series A financing - as such having the opportunity to influence your design today may make your company "investable" tomorrow.

So go to RMLSIC BioPartnering and find out what you don’t know! Why you could not even get to San Fran or Boston for $200! Here is an opportunity to secure high-quality meetings with high-quality investors in your own backyard. Without a doubt this is the best money you can spend on 9/17!

For more information and to sign-up contact the wonderful folks at CBSA:

April Giles agiles@cobioscience.com
Leah Kientz lkientz@cobioscience.com
(303) 592-4073
http://www.rmlic.com/partnering.html

DON'T MISS OUT ON THIS WONDERFUL OPPORTUNITY! SIGN-UP TODAY!

Allos THx | He Said, She Said Monday…

2009-08-31T08:07:00.004-07:00

FDA will seek input from the Oncologic Drugs Advisory Committee on Wednesday 2 September re: review of Allos Therapeutics’ (NASDAQ: ALTH) New Drug Application for pralatrexate (Folotyn); for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma. It appears as though reviewers have questioned some findings reported by the Company on the effectiveness of its proposed drug.

FDA issues with the Allos application appear to be:

The clinical significance of tumor response and duration of response, and
Whether the benefit:risk ratio is favorable

Allos reported, in-part, that 29 patients, or 27%, responded to treatment with Folotyn however, agency reviewers are challenging the verification on one or more of these responses and one or more of their associated durations.

Take a look at the FDA Briefing Document [HERE].

Don’t Call It A Comeback!

2009-08-28T13:52:00.003-07:00

Question: What do Brett Favre, LL Cool J and CLSDF have in common?

Answer: Well OK, a bit of a rhetorical question…But after nearly 14-months to the day Colorado Life Science Deal Flow, version 1.5, is back! Perhaps maybe not better than ever (yet) as we effort to shake off the cobwebs and get the digits dancing across the keyboard again; after-all, 14 months in blogosphere time equals about 6.5 people years. Nevertheless, do note that the new look and feel of CLSDF v 2.0 is well underway and has been engineered to feature all sorts of shiny new bells and whistles, guaranteed to please.* Be certain to keep a lookout for the CLSDF Version 2.0 Re-Launch Party invitation (or request your invite via email to arubenstein@rnaventures.com).

For those of you diehard CLSDF fans, and you know who you are, first of all – thank you, and second, get a life, what is wrong with you people?!?! In all seriousness, it is an incredibly humbling experience to have this blog perceived to be a valuable resource and is a wonderfully rewarding opportunity to be able to bring forth relevant content…with a twist or two.

I anticipate a bit of a shift for version 2.0, certainly life science news and stories will continue to be addressed however, the new CLSDF is not focused upon delivering breaking information about our life science eco-system. In order to keep your finger on the pulse it is highly recommended that you visit (or subscribe to…) Rocky Radar - Colorado’s Technology Record (be certain to enter your email in the life science specific box at http://www.rockyradar.com/email-subscription). The all new CLSDF will function as a platform for me to wax poetic on (primarily) life science issues and events that at times reach beyond the borders of our uniquely special home here in Colorado.

So again, thank you to all of the CLSDF readers and fans for the years of continued and steadfast support you have given me and my family. Sit back, turn up the volume, relax and enjoy…

Dont call it a comeback
I been here for years
Rockin my peers and puttin suckas in fear
Makin' the tears rain down like a mon soon
Listen to the bass go boom
Explosion overpowerin'
Over the competition Im towerin'
Wreckin' shop when I drop these lyrics that'll make you call the cops
Don't you dare stare, you betta move
Don't ever compare
Me to the rest that'll all get sliced and diced
Competitions payin' the price...

*Corporate legal insisted to include this disclaimer that CLSDF, it’s heirs, pets, lackies and bookies furnish content on this web “as-is,” without warranty of any kind, expressed, written, or implied, including but not limited to implied warranties of merchantability, fitness for a particular purpose, or non-infringement, nor can guarantee in reality the validity of any guarantee.

Thank You, Colorado. It Has Been Magical…

2008-06-26T22:25:00.005-07:00

Dear Cherished CLSDF Readers,

It is with a crashing wave of mixed emotions that I report this to be my final post as author of CLSDF. It is nearly three years to the day and over 500 posts since CLSDF launched, first as an experiment in learning about the blogosphere and new technologies yet rapidly evolved into an information node for members of the Colorado life science ecosystem and beyond.

When I began tinkering with this blog I never dreamt it would develop into the resource that you have indicated to me it is through countless emails, calls, meetings, texts, instant messages, tweets and blog comments. An infinite loop emerged, for the more acknowledgement and appreciation that was expressed by the reading audience the more motivated I became to deliver meaningful content in a consistent and reliable manner.

Perhaps the most selfish element extracted from authoring CLSDF has been the opportunity to connect with an incredibly vast array of special individuals, in Colorado and beyond. Relationships were forged that undoubtedly never would have without the blog. It truly has been an honor and a privilege and just plain fun for generating content never once felt like work to me, CLSDF is a chimera of my passions for the life sciences and the people who dedicate their lives to the advancement of global healthcare.

There have been so many people to whom I am forever indebted to and appreciative of. Too many to name here, but if you take a look at the acknowledgments page in CLSDF 2007: What’s In A Year (HERE) you will see what I am talking about. One person though whom I am moved to highlight is Robin, my betrothed, who showers me with extraordinary levels of support and encouragement; I truly feel like the luckiest man in the world to have her in my life.

As I began to share the news of the unwinding of CLSDF with community members it became unambiguously clear to me that the blog has grown to be bigger than me, and though I will no longer be banging out posts on my keyboard it is imperative that this resource continue to be available to our ecosystem. With that in mind I am actively pursuing the identification of the individual (or individuals) to whom the baton may be confidently passed. So if you enjoy looking under the hoods of life science companies, interfacing with amazing people and adding a bit of a personal flair to the news please email me (arubenstein@rnaventures.com). It may be next week or next month or next year (hopefully it does not take that long) but CLSDF version 2.0 will be back and better than ever. Perhaps you know someone who would be perfect to take the reigns, please send them my way.

Finally, I can hardly contain my level of excitement as I prepare today to embark upon my next journey. It is an extraordinary opportunity and am truly blessed to be able to participate. As a youngster I enjoyed the regular occasions to be deposited in front of the tele by Dad to enjoy with him the long running CBS series Sunday Morning, little did I know the impact that then host Charles Kuralt would have in contributing to my affinity for prose, poetry and journalism. And so I find it ironically fitting that I part levering some of his echoing words...

"Time for us to part, you and I. Saying goodbye to the readers of Colorado Life Science Deal Flow is like saying goodbye to old friends. That’s the way I feel. Thank you for making me feel that way. There is a rhyme by Clarence Day which says what I want to say: 'Farewell, my friends-farewell, and hail/I'm off to seek the Holy Grail/I cannot tell you why. Remember, please, when I am gone/'twas aspiration led me on./Tiddly, widdly, toodle-oo/All I want is to stay with you.' But...here I go. Goodbye."

GlobeImmune is Fierce!

2008-06-26T16:08:00.003-07:00

Congratulations to GlobeImmune for being named to Fierce Biotech’s 2008 Fierce 15 List (click HERE for a link to see the other 15 companies)! What makes it Fierce: GlobeImmune's third round of financing last fall was its biggest, $41.2M, bringing its total venture haul to north of $88M. Wexford capital led the round and Celgene, Boston Life Science Venture, Morgenthaler Ventures and Biogen Idec all participated. The money takes the company to a crucial inflection point: Phase II data that determines if the company's platform technology can deliver the kind of T-cell response it is looking for. GlobeImmune has three mid-stage studies underway to determine if its genetically modified recombinant yeast can induce T-cells to attack pancreatic cancer and hepatitis C.

GlobeImmune has been developing Tarmogens (Targeted Molecular Immunogens) based on scientific research in-licensed from the University of Colorado. And its development programs in divergent areas like hep C and cancer underscores just how broad a range the company could have. One successful program could lead to several more. Enrollment for the hepatitis C Phase II was wrapped in May. The study for pancreatic cancer is underway and a Phase IIa in non-small cell lung cancer--enrolling patients with a ras mutation--was launched in March. A successful mid-stage trial sets the stage for broadening the company's research activities, is likely to excite new partnership interest and also moves the company one step closer to evaluating its worth in a potential IPO.

*NOTE* Feel the power of the Colorado BioScience Association (HERE)!
*NOTE* Take a look at the new Boulder Biotech Company Tree (HERE)!
*NOTE* Read the new eBook CLSDF 2007 - What's In A Year? (HERE)!

If you enjoyed this post get free email or RSS updates (here).

Colorado: An Emerging Cluster!

2008-06-26T16:05:00.003-07:00

On the heels of last weeks publications from Families USA’s Global Health Initiative report, ranking Colorado No. 4 among states that generated the most economic activity per dollar of funding from the NIH, and the 2008 Milken Institute State Technology and Science Index ranking Colorado 3rd, trailing only Massachusetts and Maryland, based on technology and science assets and the ability to lever said assets for economic growth, comes now from Genome Technology a report on Best Biotech Places and Emerging Clusters (HERE). In addition to highlighting Colorado as a premiere emerging cluster the other US-based emerging clusters included Texas, Tennessee, Kansas, Alabama and New York. Clearly Colorado has made tremendous strides of late and remains affixed on a very promising trajectory!

BioBeers Tonight: Be There or Beware

2008-06-24T07:30:00.004-07:00

But before you attend BioBeers be certain to attend the Colorado Bioscience Association BioBoulder Networking Reception 5:30 – 7:00 at Rembrandt Yard. More info (HERE). Then just when you think it is time to head home for dinner, enjoy a summer evening with the family and walk the dog beware, because it is actually time for BioBeers 7:00 – ?, just a few blocks away at the Foundry Roof-top Deck. More info (HERE). It is an all night BioBoulder networking extravaganza.

There is also a little wrinkle thrown in for tonight. We are holding an informal poll to help determine where to feature the next BioBeers, how can you cast your vote? Simple…if you are a Denverite headed north for the night check in with me and if you are a Ft. Collinsite headed south for the night check in with me. If more friends from the north arrive at BioBeers then it is Ft. Collins for July, if more friends from the south arrive at BioBeers then it is Denver for July, and if it is a tie then it is back to Boulder for July.

*NOTE* Feel the power of the Colorado BioScience Association (HERE)!
*NOTE* Take a look at the new Boulder Biotech Company Tree (HERE)!
*NOTE* Read the new eBook CLSDF 2007 - What's In A Year? (HERE)!

If you enjoyed this post get free email or RSS updates (here).

Replidyne: Fare The Well Faropenem…

2008-06-24T07:24:00.003-07:00

An unfortunate day indeed as Replidyne (NASDAQ: RDYN) has terminated their licensing deal with Asubio Pharma for its lead drug candidate Faropenem and subsequently is expecting a charge of approximately $4.1M. Recall, Replidyne discontinued enrollment in a late-stage study testing its faropenem medoxomil oral antibiotic as a treatment for patients with acute chronic bronchitis due to an inability to secure a partner for the clinical program.

Concomitant to the terminated license agreement is termination of the supply agreement with Nippon Soda Co. Engineering costs and delayed compensation fees comprise a portion of the expected $4.1M charges.

The decision to end Faropenem is disappointing in a variety of dimensions and to a certain extent somewhat surprising that a partner could not be identified given how mature the asset is. The termination decision was executed in order to preserve cash and focus attention on the previously discussed strategic initiatives of the C. difficile infection program and novel anti-infective programs based on DNA replication inhibition technology. As of 31 May Replidyne had cash and short term investments totaling $71.5M.

*NOTE* Feel the power of the Colorado BioScience Association (HERE)!
*NOTE* Take a look at the new Boulder Biotech Company Tree (HERE)!
*NOTE* Read the new eBook CLSDF 2007 - What's In A Year? (HERE)!

If you enjoyed this post get free email or RSS updates (here).

Back in the Saddle...

2008-06-23T09:07:00.002-07:00

I’m playing catch-up today after attending the week long BIO2008 conference last week. It was an incredible experience (again) on a variety of levels and so too was the opportunity to again be an invited conference guest blogger. Despite the technological hurdles faced I was able to get to a few postings, here is a review and links:

Something Funny on the Way to a Breakout Session

2008-06-18T10:51:00.003-07:00

Sitting in amazement of the logistical tango displayed by the BIO organizers on just exactly how does one feed 20,000+ attendees in a sophisticated and elegant manner, needless to say the Keynote Luncheon #1 was executed to perfection. Whilst hacking away at a blog post my PC endured the dreaded blue screen of death. What’s worse is that the drive has spun out into an infinite loop of blue-screen-reboot-repeat. Not so funny…luckily I have access to the beautifully appointed BIO media/press room. Thank you BIO! So the posts may not come as fast and furiously as was anticipated. Oh well, best laid plans of mice and men…

A reader of the AR Post’s will undoubtedly pick up a common denominator, that being Colorado, for obvious reasons, as I write the Colorado Life Science Deal Flow blog. I could barely contain my excitement while in the first Breakout Session Do You Have a Clue What Big Pharma is Looking For?, not one, not two but three Colorado companies/assets were mentioned in the first few breaths of the panelists, they being:

Pharmion
Array Biopharma
Macugen

Whilst departing lunch, head hung low as a result of my technological woes with one seemingly former laptop, I could not make it a ten-feet without running into a few more Colorado biocompatriots including Dan Stinchcomb, President & CEO of InViragen and Rick Silva, Director of the University of Colorado Technology Transfer Office .

Back to the Breakout Sessions Finance Track for Ice Cold to Red Hot: Turn-Around in the Diagnostics Value Proposition. Hope to see you at the party tonight on the USS Midway.

BIO-EVE and BIO Day 1 – Anticipated Fashion Faux Pas

2008-06-17T07:17:00.006-07:00

Having evolved into now a BIO veteran has yielded some very important lessons for a successful conference, one in particular that has resonated is - wear comfortable shoes. There is a lot of walking to be done over the four days and therefore I have elected to choose function over fashion and swap out the Ferragamo and Prada loafers for my running shoes with my back-saving orthotic inserts. So please refrain from summoning the fashion police when you see the zapatos paired with the Gucci and Armani on top…I and my pain free back thank you.

If you happen upon my friend Steve Albainy-Jenei from Patent Baristas early in the day in the exhibit hall be certain to ask him for a iBarista iPod, no easier iPod giveaway that I am aware of, more info (here).

Tomorrow is certain to be an action packed day however, I am already looking forward to the evening activity – the Welcome Reception Party – at the USS Midway Aircraft Carrier. Please stop me and at the party and say hi. And now a few sights from BIO-EVE:

myBIO2008 Mobile = Value-add

2008-06-17T07:13:00.003-07:00

Technology has permeated all aspects of BIO2008, one of the coolest additions is the myBIO mobile addition, this offering may come in handy (pun intended) for all of you Blackberry and iPhone addicts. The value proposition is multifold, in the palm of your hand one may simply:

Locate exhibitors and booth numbers
Locate sessions (by date/time/place)
Build a ‘visit plan’
Even book reservations for hotels, restaurants or call a cab

I’ve installed myBIO on my Blackberry Curve. It took a little tinkering to get up and running and perhaps these hints my make your installation efforts seamless.

Before you start have your badge number handy (you can find this on your registration confirm email or if you have it already the number is hanging around your neck)
If you have a US cell number there is no country code necessary
Enter your mobile number (HERE) to get going (if the link is broken copy/paste http://mybio.boopsie.com/v2/txt/
A text will be sent to your device, click on the link
Be certain to then select the corresponding download option that correlates with your devices operating system. This is where problems may occur if you select the wrong version to install. Not to fret however, if the wrong version is installed simply uninstall, find the correct version and install
Once installed be certain to reboot your device

Finally, the application icon on your mobile desktop is called “Boopsie”, click on that and you are off to the races. Enjoy. If you are having problems shoot me an email at arubenstein@rnaventures.com.

Follow Me on the BIO2008 Blog!

2008-06-13T10:47:00.004-07:00

And the new BIO2008 blog, BioOnTheRoad, is off to the races (http://BioOnTheRoad.org). I will be blogging there for the next week covering the BIO2008 conference live from San Diego. There will also be a blog feed to the conference homepage at http://BIO2008.org. Where appropriate I will cross blog certain posts. Right now you can subscribe via RSS, I'll see if we can get and email subscription option going too.

CLSDF: Subscriber Growth Update

2008-06-12T07:36:00.004-07:00

I am excited to announce CLSDF has added another 100 subscribers; the blog is now north of 500, passing the 400 mark only 3 months ago in March. My infinite appreciation to all of you for subscribing, your feedback (both positive and negative) is treasured and motivating.

If you find CLSDF to be of continuing value than I ask that you inform your friends and colleagues about the resource and let them know how easy it is to become a subscriber. Simply send them a link to http://CLSDF.com. Thank you!

A few other quick reminders:

If you are interested in forwarding a particular post to someone simply click on the ‘Email This’ tab at the bottom of each post
At the bottom of each post are also options to add a particular post to your DEL.ICIO.US, Facebook, Digg or StubleUpon accounts
Looking to do some networking? Be certain to attend the next BioBeers, more info (HERE). Next event 24 June 7:00pm to immediately follow the CBSA BioBoulder 5:30 event.
If you are looking for the CLSDF, 2007 – What’s In A Year? ebook you can read it (HERE)

Finally, thank you all for your continued support! The Colorado life science ecosystem is positioned at a unique time and place, filled with inspiring entrepreneurs and skilled and passionate people who help effectively move discoveries along the commercialization pathway; I am both honored and humbled to be along for the ride as Colorado ascends towards greatness.

Ceragenix Pilot Study Results for EpiCeram®

2008-06-12T07:32:00.004-07:00

Ceragenix Pharmaceuticals (OTCBB: CGXP) announced positive results from its investigator-blinded pilot study comparing the safety and efficacy of EpiCeram® Skin Barrier Emulsion to that of Elidel® cream from Novartis (NYSE: NVS), a standard non-steroidal therapy in the treatment of mild-to-moderate pediatric atopic dermatitis (AD). Both EpiCeram® and Elidel® cream produced significant improvement in patients’ conditions after four weeks of treatment. There were no statistically significant differences between the groups treated with EpiCeram® compared to those treated with Elidel®.

Improvement in patient AD was a secondary endpoint of the study. Both treatments demonstrated a statistically significant reduction. Itching, a hallmark symptom of AD, was another secondary endpoint of the study. Both EpiCeram® and Elidel® cream produced significant relief from itching after 28 days of treatment, and there was no statistically significant difference between the two treatments in reduction of itching at this time point. The research was conducted by clinicians at the Oregon Health & Sciences University and the University of California School of Medicine, San Diego.

Atopic dermatitis is a chronic childhood skin condition that may affect patients for many years. Dermatology agents currently used to treat atopic dermatitis and other inflammatory skin disorders have limitations of use due to various safety concerns. The use of EpiCeram® does not raise any of the safety concerns associated with the use of topical steroids or topical immunosuppressants.

QLT Reaches $140M Agreement with Allergan

2008-06-10T20:08:00.003-07:00

QLT, Inc. (NASDAQ: QLTI) announced that QLT USA, its wholly-owned subsidiary, has entered into an asset purchase agreement with Allergan (NYSE: AGN) to fully divest QLT’s worldwide rights to Aczone®, a prescription topical medicine approved in the United States and Canada for the treatment of acne vulgaris. Under the terms of the agreement, QLT will receive a one-time cash payment of approximately $140M, and is expected to close in 3Q08.

The Aczone® asset purchase agreement is the second agreement entered into by the Company to divest non-core assets since it announced its strategic restructuring earlier this year. Other assets offered for sale from QLT USA include Eligard® and the Atrigel® drug delivery system.

*NOTE* Feel the power of the Colorado BioScience Association (HERE)!
*NOTE* Take a look at the new Boulder Biotech Company Tree (HERE)!
*NOTE* Read the new eBook CLSDF 2007 - What's In A Year? (HERE)!

If you enjoyed this post get free email or RSS updates (here).

SomaLogic + Otsuka = Early Detection + Diagnosis

2008-06-10T20:03:00.005-07:00

Otsuka Pharmaceutical entered into a collaboration agreement to use SomaLogic’s proprietary aptamer technology to discover and develop novel diagnostic products and to design research tools that will enhance Otsuka’s discovery and development efforts.

SomaLogic will receive research funding and will be entitled to receive a royalty on any marketed products developed as a result of the collaboration. Otsuka also received an option to acquire distribution rights in Asia for certain SomaLogic clinical diagnostics products. In addition, SomaLogic received an equity investment from Otsuka. Other financial terms were not disclosed. Finally, note that SomaLogic is hiring! Take a look (HERE).

*NOTE* Feel the power of the Colorado BioScience Association (HERE)!
*NOTE* Take a look at the new Boulder Biotech Company Tree (HERE)!
*NOTE* Read the new eBook CLSDF 2007 - What's In A Year? (HERE)!

If you enjoyed this post get free email or RSS updates (here).

Thom Cech on 60 Minutes

2008-06-10T07:49:00.004-07:00

Colorado life scientist’s and life science companies have recently been appearing left and right in the national spotlight, first in Popular Science then in Newsweek and now…Did you happen to catch 60 Minutes this past Sunday night? If not, the segment on Howard Hughes and how the Howard Hughes Medical Institute came to fruition featured one Colorado-bound Thom Cech. If you have a few moments you can watch the video below, in addition is a video interview of Thom that I find very interesting and hope you will too [if you are reading this via email or RSS aggregator you will have to click over to http://CLSDF.com to view the videos].

*NOTE* Feel the power of the Colorado BioScience Association (HERE)!
*NOTE* Take a look at the new Boulder Biotech Company Tree (HERE)!
*NOTE* Read the new eBook CLSDF 2007 - What's In A Year? (HERE)!

If you enjoyed this post get free email or RSS updates (here).

Allos: Positive Phase I Interim Data for PDX

2008-06-08T16:27:00.003-07:00

Allos Therapeutics (NASDAQ: ALTH) announced positive interim data from their Phase I dose optimization study of PDX (pralatrexate) with vitamin B12 and folic acid supplementation in patients with relapsed or refractory cutaneous T-cell lymphoma (CTCL). The data demonstrated activity in a range of doses, and will continue with the objective of determining the optimal dose and schedule for patients with CTCL.

Data were presented on 17 patients, including 14 evaluable patients who completed at least one cycle of treatment with PDX at doses ranging from 15-30 mg/m2 as part of a weekly schedule for two or three weeks followed by one week of rest. Patients received a median of three prior systemic therapies. Investigator-assessed responses were observed in 7 of 14 evaluable patients, including two complete responses and five partial responses. Responses were observed in all four treatment cohorts. The most common adverse event was mucositis.

*NOTE* Feel the power of the Colorado BioScience Association (HERE)!
*NOTE* Take a look at the new Boulder Biotech Company Tree (HERE)!
*NOTE* Read the new eBook CLSDF 2007 - What's In A Year? (HERE)!

If you enjoyed this post get free email or RSS updates (here).

GambroBCT is Now CaridianBCT

2008-06-05T07:12:00.004-07:00

Perhaps 2008 will commemorate a year of transition for the Colorado life science ecosystem marked now by a third company to announce a name change.

CaridianBCT origins date back to 1964 when founders Bob Collins and Ran Bellows established COBE Laboratories to meet emerging needs for custom heart-lung tubing packs. COBE evolved into a market leader in the blood component technology and medical specialty products industry. In 1990, Sweeden-based Gambro AB acquired COBE to form GambroBCT. And now a new name change, from GambroBCT to CaridianBCT, has been architected to emphasize business unit independence from the parent company and concurrently enhance its global branding efforts.

It’s exciting to see CaridianBCT continue its storied history and new chapter as a leading global provider of technology, products and services in automated blood collections, therapeutic systems, whole blood processes and pathogen reduction technologies - serving blood banks, hospitals and clinical and biotech research facilities. Headquartered in Lakewood, CO., the company is Colorado’s largest medical device manufacturer with global revenues nearing $500M with operations in 32 countries and 1,800 of their 2,300 employees call the Rockies home.

*NOTE* Feel the power of the Colorado BioScience Association (HERE)!
*NOTE* Take a look at the new Boulder Biotech Company Tree (HERE)!
*NOTE* Read the new eBook CLSDF 2007 - What's In A Year? (HERE)!

If you enjoyed this post get free email or RSS updates (here).

$76.1M From NIH to Fund CCTSI

2008-06-04T07:19:00.003-07:00

Congratulations to the University of Colorado Denver for receiving a $76.1M five-year grant from the NIH designed to accelerate scientific discovery towards commercialized products, improve patient health and fulfill the critical need to train the next generation of clinical and translational researchers. These goals and more are to be achieved within the virtual walls of the newly established Colorado Clinical and Translational Sciences Institute (CCTSI).

The Institute’s five areas of focus are: converting laboratory research to clinical use, applying clinical lessons in communities, discovering new methods and applying technologies to measure and analyze data, training future researchers and advancing child and maternal research. CCTSI will achieve its aims via the architecting of an unprecedented regional partnership among the UC Denver Schools of Medicine, Dentistry, Pharmacy, Public Health, Graduate School and College of Nursing, as well as CU-Boulder, University of Colorado Hospital, The Children's Hospital, Denver Health, National Jewish Medical and Research Center, the Denver Veterans’ Affairs Medical Center and Kaiser Permanente of Colorado.

The NIH created the Clinical and Translational Science Award to stimulate collaboration between leading academic health centers, health care organizations, the private sector and the communities they serve. The result is a historically large public investment in health care research and training that promises to pay similarly large and historic dividends. The CCTSI will conduct state-of-the art clinical research, under careful oversight to assure participant safety.

The University of Colorado Denver join the following institutions who have received similar funding from the National Institutes of Health’s Clinical and Translational Science Award consortium:

Albert Einstein College of Medicine of Yeshiva University
Boston University
Harvard University
Indiana University School of Medicine
Northwestern University
The Ohio State University
The Scripps Research Institute
Stanford University
Tufts University
The University of Alabama at Birmingham
The University of North Carolina at Chapel Hill
The University of Texas Health Science Center at San Antonio
The University of Utah

For a bit more depth be certain to observe the powerpoint below presented by Ronald Sokol, MD Director of CCTSI (If reading this in an email or RSS feed pop over to http://CLSDF.com to observe the slide deck).

| View |

*NOTE* Feel the power of the Colorado BioScience Association (HERE)!
*NOTE* Take a look at the new Boulder Biotech Company Tree (HERE)!
*NOTE* Read the new eBook CLSDF 2007 - What's In A Year? (HERE)!

If you enjoyed this post get free email or RSS updates (here).

Pages of Newsweek Featuring Ventria Bioscience

2008-06-03T08:13:00.004-07:00

On the heels of Tensegrity Prosthetics prominent feature in Popular Science (HERE) comes a recent Newsweek article (HERE) presenting a high level description of the green gene revolution or the marriage of biotechnology and agriculture. When referring to the art of leveraging agricultural products as therapeutics manufacturing plants (no pun intended…well maybe) Ventria Bioscience (Ft. Collins) was emphasized for some of their recent work.

Ventria has developed their proprietary ExpressTec technology platform – a protein/peptide production system – designed to create innovative human health products that incorporates self-pollinating crops (such as rice and barley) as the production host for these products, thereby bypassing many of the technological hurdles inherent in other protein production methods. Certain benefits of ExpressTec production process include: i) Economically advantaged expression capability (e.g. 10g/kg of brown rice) ii) Scalability for large volumes of recombinant proteins/peptides with minimal capital investment compared with other systems iii) Free of infectious or toxic contaminants iv) Self-pollinating crops provide a safe and closed production system and v) Efficient supply management - the protein/peptide can be stored in its lowest cost form for multiple years.

Ventria's ExpressTec platform has produced several proteins that have a variety of applications in human and animal health. Two specific products include recombinant human Lactoferrin and Lysozyme which are both found in human breast milk as well as most epithelial surface secretions including tears, nasogastric, saliva, and bronchial. Potential applications are in GI health for the management of acute diarrhea and certain bacterial, viral and fungal infections.

*NOTE* Feel the power of the Colorado BioScience Association (HERE)!
*NOTE* Take a look at the new Boulder Biotech Company Tree (HERE)!
*NOTE* Read the new eBook CLSDF 2007 - What's In A Year? (HERE)!

If you enjoyed this post get free email or RSS updates (here).

Pre-BIO Conference Colorado Networking Event

2008-06-02T08:08:00.004-07:00

Do you plan to attend BIO in two weeks? If so be certain to attend the Colorado pre-conference networking reception on 10 June 5:00 – 6:30pm at the Governor’s Mansion Carriage House. Be certain to RSVP if you are planning to attend, contact Becky Chandler 303.892.3707 or becky.chandler@state.co.us. We can thank the Colorado Bio Science Association and the Colorado Office of Economic Development and International Trade for sponsoring this first official BIO 2008 event!

By the way, Governor Ritter plans to attend the BIO conference and here are a few of his thoughts on our eco-system.

"I am very excited to showcase Colorado's commitment to the bio- and life-sciences during the upcoming BIO 2008 event in San Diego," Colorado Gov. Bill Ritter said. "Colorado’s bioscience community is making incredible advances and we have a tremendous success story to tell. We recently established a Colorado Bioscience Grant Program to promote the industry and facilitate tech transfer. Colorado’s first Nobel Laureate, Tom Cech, just announced his return to the state. Our Anschutz Medical Campus at Fitzsimons and the research and development work being done in Boulder and Fort Collins are making Colorado a regional bioscience hub. My administration has made the biosciences one of the focal points of our overall economic-development strategy, and by elevating the stature of this crucial Industry of the future, we are competing on a national and international level.”

Taligen Founders Interviewed on w3w3

2008-06-02T07:58:00.003-07:00

Larry Nelson does fantastic work with w3w3, “Colorado’s Voice of the Technology Community”. Most recently he interviewed Taligen Therapeutics co-founders, CSO V. Michael Holers, MD and President & CEO Woodruff Emlen, MD. Take a listen here to learn more about how Taligen levered their proof-of-concept funding to a $65M Series B financing (HERE). If the link does not work simply paste this url in your browser for the podcast: http://www.w3w3pc.com/CUTTO/Taligen.Therapeutics_W.Emlen_M.Holers.mp3

BioBeers Next Meeting: 24 June

2008-06-02T07:46:00.003-07:00

As the Chairman of the Board sang, ”Start spreading the news…” The next BioBeers is set for 24 June at 7:00pm in Boulder at The Foundry roof-top deck; one of the best roof-top views in all of Boulder. We have ordered a beautiful starry night as backdrop for plenty of bio-networking, a little bio-bacchanalia and, some bio-tomfoolery too.

Boulderites have been clamoring for a BioBeers, well here you have it, we hope to see the Bio-Boulderites show up en mass, for a strong turn out will ensure subsequent gatherings; let’s see if Chief Niwot’s curse applies to BioBeers as well.

When: Tuesday 24 June 7:00pm
Where: The Foundry, 1109 Walnut St. Boulder 80302

As always please kindly RSVP with the click of a mouse at BioBeers.com. Thanks and see you soon for a cold one…

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CLSDF: Gone Fishin’, Back June 2nd

2008-05-22T21:27:00.004-07:00

That’s right we here at CLSDF are closing up shop for the week, it is time for a little R&R, but not too much. We have an ambitious schedule planned starting with an Egyptian excursion to the Pyramids, the Great Wall, Shanghai and Beijing, the Taj Mahal, Dehli and the Sariska tiger reserve, Machu Picchu, the Galapagos and Lima, and finally, a swing back through the Grand Canyon. Lot’s to do so we better get it started. As always…thanx so much for your continued readership and support. Please let your friends and colleagues know about the CLSDF email subscription options and finally, if you have any tips or treats for CLSDF be certain to forward them to arubenstein@rnaventures.com. See you back here on Monday June 2nd.

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Miragen Therapeutics: Series A $8M

2008-05-22T21:24:00.003-07:00

Miragen Therapeutics, a biopharmaceutical company focused on the discovery and development of therapies for cardiovascular and muscle disease based on microRNA biology has closed an $8M Series A financing co-led by Atlas Venture and Boulder Ventures. The Miragen scientific co-founders include successful academician serial entrepreneurs Eric Olson, Ph.D., Michael Bristow, M.D., Ph.D., and Marvin Caruthers, Ph.D.

This financing should enable the Company to define key microRNA’s, identify clinical indication(s) [perhaps post-myocardial infarction], ramp operations, complete large animal efficacy studies and generate a lead. Critical to the success of Miragen is the capacity to overcome bioavailability challenge of nucleic acid-based therapeutics; the Company may address said issue perhaps by the direct delivery of their miRNA’s to the heart.

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ARRY-886 Widening the Phase II Funnel

2008-05-21T21:38:00.002-07:00

Array BioPharma (NASDAQ: ARRY) and AstraZeneca (NYSE: AZN) recently announced plans for two additional randomized Phase II trials for ARRY-886, an oncology small molecule inhibitor targeting the Ras/Raf/MEK/ERK signaling pathway. The trials, scheduled to initiate in 2H08, will test ARRY-886 in combination with chemotherapeutic agents in melanoma and non small cell lung cancer patients.

Recall back in December 2003, Array entered into an out-licensing and collaboration agreement with AstraZeneca to develop the MEK program in the field of oncology. Under the agreement AstraZeneca acquired exclusive worldwide rights to the clinical development candidate ARRY-886, along with ARRY-704 and an additional second-generation compound for oncology indications developed during the collaboration. Array retains the rights to all non-oncology therapeutic indications for MEK compounds not selected by AstraZeneca for development. To date Array has earned $21.5 million in up-front and milestone payments. The agreement also provides for research funding, which is now complete, and potential additional development milestone payments of approximately $75 million and royalties on product sales. AstraZeneca is responsible for further clinical development and commercialization of ARRY-886 and ARRY-704 and for the third compound they licensed.

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Tensegrity Featured in Popular Science

2008-05-21T21:33:00.003-07:00

Congratulations to Jerome Rifkin and Tensegrity Prosthetics for their wonderful feature in the June edition of Popular Science! Read the article (here) then be certain to watch the video (here).

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Allos: Encouraging Data = Next Round of Financing

2008-05-20T06:51:00.004-07:00

On the heels of Allos Therapeutics (NASDAQ: ALTH) reporting of positive interim data for their pivotal Phase II PDX (pralatrexate) trial, where a 29% of 65 T-cell lymphoma patients had either a complete or partial response, have now unveiled their follow-on financing strategy for ongoing clinical requirements in addition to preclinical R&D of pipeline candidates, manufacture of clinical trial material, pre-commercial scale-up activities for PDX, working capital and general corporate purpose needs. That is the planned sale of 9.00M shares of newly issued common stock with up to an additional 1.35M shares available to cover over allotments. Banc of America and Citigroup are acting as co-lead underwriters on the financing which is expected to be declared effective early in June. Recall Allos last issued 9M shrs about a year and a half ago raising just north of $50M; if this new financing is priced similarly at $6/share one could expect the deal to bring in approximately $62M less expenses.

*NOTE* Feel the power of the Colorado BioScience Association (HERE)!
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When It Rains It Pours - Replidyne Served

2008-05-19T05:43:00.003-07:00

Replidyne (NASDAQ: RDYN) has been served with a Demand for Arbitration from MEDA Manufacturing alleging that the Company breached its obligations under a 2005 supply agreement. In April 2007, Replidyne provided notice to MEDA of its termination of the Supply Agreement in accordance with certain termination provisions, and believes that it did not have any obligations to MEDA under the Supply Agreement beyond May 2007.

The Demand seeks damages for breach of contract in the amount of approximately $2.3M plus interest and reimbursement of attorney fees and other costs incurred in proceedings. In addition, the Demand requests a judgment that Replidyne's termination of the Agreement was ineffective and that there is an obligation to continue to make annual minimum payment amounts of approximately $3.6M to MEDA remain in effect. If termination of the Agreement is determined to be ineffective Replidyne may also remain obligated additional future fees of up to approximately $2.6M (total approximating $$9.5M). Replidyne plans to vigorously defend itself against the allegations made in the Demand

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Valuation in Life Sciences: A Practical Guide

2008-05-16T07:27:00.005-07:00

Some people read the Old Testament, others may read the New Testament, the Koran, the Bhagavad Gita, or the Guru Granth Sahib, my bible has become…V aluation in Life Sciences: A Practical Guide by Dr. Boris Bogdan and Ralph Villiger. This work has emerged as my one unambiguous go-to text when it comes to evaluation and valuation needs.

Just when I thought the risk adjusted net present value (rNPV) was the model for biotech and pharma valuation work Dr.’s Bogdan and Villiger have opened my eyes (and spreadsheets) to the world of real option valuation (ROV). What is key and fundamental to ROV theory is the development of a project (or company or patent or license or M&A transaction or stock, etc.) is dependent upon the changing market conditions of the real world and the sensitivity to incorporate this dynamic nature into the modeling versus discounted cash flow approaches where the modeling is static and predefined and thus unaccommodating to the dynamic market fluctuations of the real world.

Anyone who has ever sat down to model out a valuation of biotech or pharma assets that are yet to reach market, either pre-NDA, in the clinic or even pre-IND well there are a basket of hurdles (to say the least) associated with achieving a meaningful analysis. Leveraging the tools provided in Valuation in Life Sciences provides a road map on just how to achieve meaningful and flexible analyses. If you are in start-up mode, tech transfer, business development, finance or even still in business school do yourself a favor and pick-up a copy, you will not be disappointed!

UPDATE:

The authors are holding a one-day workshop (6 June in San Francisco, at the Fairmont Hotel and 16 June in San Diego, at the Sheraton Hotel and Marina). Sounds like it will be an incredible day focused on:

Structure valuation models in Excel
Source input parameters (success rates, durations, costs)
Structure license contracts to bridge differing assumptions between licensor and licensee
Analyze and interpret license contracts for licensor and licensee in terms of: rNPV, IRR/ROI and Value share

For more information and registration information click (HERE) or follow this link: http://www.avance.ch/newsletter/Invitation/Workshop_June.pdf

I hope to attend the San Diego workshop, if you are planning to attend too shoot me an email (arubenstein@ranventures.com) and let’s connect.

*NOTE* Feel the power of the Colorado BioScience Association (HERE)!
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Alphasniffer is now BiOptix

2008-05-14T07:42:00.003-07:00

It is not the first, will not be the last, name change that is. Alphasniffer (Boulder) has announced a new corporate identity, introducing…BiOptix. This modification in moniker echoes how the Colorado life science ecosystem is certainly maturing from a research and discovery engine to the logical progression of more of a commercialization focus, this second corporate name change announced in 2008 validates our regions evolution.

Corporate re-branding is not unique to the life sciences. I’ve listed a few name changes that you may or may not have been aware of. See how many of the list below you would have guessed correctly, the names on the left were the predecessors:

WAS Anderson Consulting IS Acenture
WAS Philip Morris IS Altria
WAS KPMG IS Bearing Point
WAS Backrub IS Google
WAS Computing Tabulating & Recording IS IBM
WAS Kentucky Fried Chicken IS KFC
WAS Jerry’s Guide to the WWW IS Yahoo
WAS United Telephone IS Sprint
WAS Tokyo Telecom IS Sony
WAS Brad’s Drink IS Pepsi
WAS Matsushita Electric IS Panasonic

BiOptix, established in 2003, is developing a proprietary technology for real-time, sensitive, label-free detection of medically and commercially important molecules such as DNA, proteins, toxins, contaminants and other compounds. Applications using this broad technology platform include real-time detection instruments for markets such as medical research, personalized medicine and diagnostics, pharmaceutical process control, defense and homeland security, and numerous other industrial demands. The core technology, known as SPR-CPI, was invented at BiOptix by Dr. John Hall, 2005 Physics Nobel Prize Laureate. Congratulations to Misha Plam, Slava Petropavlovskikh, Oyvind Nilsen and the entire team at BiOptix for achieving this maturation milestone!

A if for Agilent, B is for Boulder, C is for Nucleic Acid

2008-05-13T07:39:00.002-07:00

Did you know that Agilent Technologies (NYSE: A) provides bio-analytical and electronic solutions to a variety of industries; the company's bio-analytical measurement business segment provides application-focused solutions that include instruments, software, consumables, and services that enable their customers to identify, quantify, and analyze physical and biological properties. Its product categories include gas chromatography, liquid chromatography, mass spectrometry, microfluidics, microarrays, atomic force microscopy, PCR instrumentation, software and informatics, and related bioreagents, as well as consumables and services.

A portion of that bioreagent business sits squarely in the middle of Boulder, as a result of the 2006 acquisition of SynPro, where the focus is on large-scale nucleic acid synthesis and purification for pharmaceutical ingredient manufacturing. Now the $5B a year Agilent plans to grow the Boulder nucleic acids unit as a result of another recent acquisition of the Dowpharma Nucleic Acid business unit. It is expected that up to thirty new hires will be made at the Boulder campus. Bring it!

Replidyne Provides 2008 Guidance

2008-05-09T07:28:00.003-07:00

Yesterday Replidyne (NASDAQ: RDYN) held their annual shareholder meeting and 1Q08 conference call. With an anticipated burn rate of approximately $10M per quarter Replidyne’s current cash position just north of $78M positions operations to continue well into 2009. Considering the new strategic initiatives including restructuring, cash conservation and the difficult decision to terminate enrollment of the Phase III faropenem study management laid out the company plans to move forward with the C. difficile program with the goal of initiating a Phase I trial with REP 3123 as well as identifying an IND candidate from the DNA replication inhibition program. A spectrum of business development activity appears to be transpiring, though no details have been made public, some of which include: i) partnering talks are ongoing ii) looking at M&A opportunities, whereby the large cash position may make Replidyne more attractive to enable opportunistic actions and iii) a large international investment bank has been appointed to bring forth potential US and ROW opportunities, after all...the current market is frothy with deals. Needless to say with Replidyne’s seasoned and sophisticated management team it will not be surprising to see the share price and faropenem development pulled sharply out of their nose dives.

*NOTE* Feel the power of the Colorado BioScience Association (HERE)!
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BioBootCamp Day 1: Getting In Shape

2008-05-09T07:23:00.002-07:00

It was buzz cuts and pushups, nuts and bolts, project management and IP protection, reimbursement and regulatory, & compliance and management teams all crammed into Day 1 of BioBootCamp, whoa, I am exhausted and we are only half-way through. Yes sir! Not only has the content been fantastic and the presenters polished, motivated and interactive but something interesting has happened this year on the recruit side…attendance has more than doubled from years past, and now the once vast double conference room, provided by the very gracious hosts at Holland and Hart, appears to be bursting at the seams, even with the no-shows (more laps for you when you arrive today). It was a wonderful feeling to look around the room and not recognize so many people. My take home after Day 1 is that there is even a higher interest/activity in entrepreneurial endeavors than anticipated. The room was bursting with MD’s, Ph.D.’s, MD/Ph.D.’s not to mention the MBA’s, industry folks, soon-to-be, first-time and serial-entrepreneurs…just an absolutely wonderful cross-section in attendance. Looking forward to Day 2…I had better start stretching.

Where Does Pharmion Go From Here?

2008-05-08T20:15:00.003-07:00

In a recent interview with the Star-Ledger, New Jersey-based Celgene (NASDAQ: CELG) Chief Executive Officer Sol J. Barer, Ph.D. provided some insight as to the integration plans for Pharmion products and intellectual capital. Following is a portion of that Q&A.

Q: Celgene already was expanding its presence abroad. What does adding Pharmion do for you internationally?

A: We have a sales force all over Europe right now. We have a very good infrastructure that's very leveragable. We're selling Revlimid, and doing very well right now. With the Pharmion integration, we're adding thalidomide, which is approved in first-line multiple myeloma (in Europe). Revlimid is approved in relapsed or previously treated multiple myeloma. We also have a marketing approval for Vidaza, the first therapy that will show a survivability advantage in patients. Rather than partner, what we do is retain the value for our shareholders by building our own infrastructure - clinical, regulatory - around the world. We'll use distributorships in certain countries or certain regions.

Q: What happens to Pharmion's operations? Will you keep any presence in Colorado?

A: We're going through the integration planning process. We're looking at as many positions and many levels and all the products. We're very impressed with with a lot of people there, at all levels. As you combine two commercial, public entities, you don't need two CFOs, you don't need two CEOs -- thank god. There's clearly going to be overall consolidation. What we're going to try to do is retain as many of the people that are motivated and excited to stay with Celgene.

Q: A year ago, you said you might be looking for bigger quarters around Summit because the company was growing and you disliked satellite offices. What are your plans now?

A: We'll have multiple sites. (Pharmion) has a major clinical site in Kansas City, which we'll keep. We'll probably be adding a building or buildings here on-site. We've gotta live with the fact that there'll be multiple locations with the major company we're becoming. I'm pleased to say the sun never sets on Celgene, to borrow a phrase. It's difficult. We're used to addressing the company all at once, and now that can't happen. If it's 7 o'clock in the morning here, it's 9 at night in Japan but 4 in the morning in California. So when we try to have meetings, we try to move them around.

Q: Even before Pharmion, Celgene seemed to be stepping up its licensing and partnership deals. Will that continue?

A: A lot of these are driven by specific opportunities that often are difficult to predict. There will be a period of time subsequent to the Pharmion acquisition where a lot of integration will go on. While that will not affect the smaller deals, it probably will affect the larger collaborations, which would be a lower priority while we're integrating the new company.

Q: How has your job changed in the past year?

A: One of the big challenges is really, as we grow, to maintain the entrepreneurial spirit, the almost family atmosphere that's characterized Celgene through the years. I think that's been important to our success. I view that as one of my greater challenges.

*NOTE* Feel the power of the Colorado BioScience Association (HERE)!
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GW Carver Award to Gevo CEO

2008-05-07T18:58:00.004-07:00

Perhaps not on many peoples radars…yet…Gevo (Denver) a next generation bio fuels company recently moved to town from Pasadena and Cal Tech, from where their intellectual property originates. Backed by Khosla Ventures and Sir Richard Branon’s Virgin Green Fund Gevo incorporates three novel technological elements enabling the scalable production of biofuels.

Recently during the World Congress on Industrial Biotechnology and Bioprocessing, BIO presented the first annual George Washington Carver Award to Gevo CEO Pat Gruber, Ph.D., MBA in recognition of his accomplishments in creating and commercializing a new plastic made from annually renewable resources.

Prior to joining Gevo, Dr. Gruber was the President and CEO of Outlast Technologies and held several management positions at Cargill. He has also served as President and CEO of Lactech, a technology development company, and was one of the founders of NatureWorks where he was the VP of Technology and Operations and Chief Technology Officer from 1997 until 2005. Dr. Gruber has served as a member of the Federal Advisory Committee for Biomass R&D and the Advisory Committee for the Energy Future Coalition and currently serves on the board of directors of Outlast Technologies, Gevo, Segetis, and Green Harvest Technologies.

Congratulations to Dr. Gruber and the entire team at Gevo and WELCOME TO COLORADO! We are thrilled you have made your new home here!

*NOTE* Take a look at the new Boulder Biotech Company Tree (HERE)!
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BIO2008 + Twitter = Follow Me @arubenstein

2008-05-07T18:50:00.005-07:00

Though still over a month away I am gearing up for BI0 2008 and yes blogging is part of the plan however, I will be posting ‘tweets’ via Twitter documenting my live experiences throughout the entire conference, as opposed to regular blog posts that I will get to at the end of the days. Twitter is a micro-blog; it allows for very short posts yet is extremely quick & easy to use. If interested, take a look at this video (if reading this post in email or RSS feed you will have to cruise on over to http://CLSDF.com to view it) for a quick explanation of Twitter. If so moved go and set up an account at http://twitter.com be sure to follow me @arubenstein and send a tweet if you wish for me to follow you back. As BIO approaches I will talk more about how to make accessing Twitter even simpler and easier than the web browser offering. Stay tuned...

Twitter in Plain English from leelefever on Vimeo.

*NOTE* Take a look at the new Boulder Biotech Company Tree (HERE)!
*NOTE* Read the new eBook CLSDF 2007 - What's In A Year? (HERE)!

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Array BioPharma: Secures $80M Debt Facility

2008-05-06T07:31:00.003-07:00

With over $116M in cash on the books as-of 31 March that did not keep management at Array BioPharma (NASDAQ: ARRY) from securing an additional $80M debt facility from Deerfield Management. Deerfield currently holds in excess of 4.7M shares of Array or nearly 10% of the company. This new debt round will be drawn down in two $40M tranches in June and December of 2008.

Needless to say how costly it is to commercialize a drug, depending on the source a common number used today is $800M and about ten years to reach the market. Now think about that cost for a single agent, small molecule, biologic etc. relative to the incredibly robust pipeline at Array where there are currently six compounds in the clinic for oncology and inflammation, and add to that the work ongoing in the discovery program…$116M simply may not provide enough dry-powder to get a single candidate to the finish line, but at this point financing events are rather often about achieving value-inflection based milestones, like demonstrating proof-of-concept, an IND filing or moving a compound into or advancing in the clinic, and not getting to market.

So how does management raise the requisite financings to achieve such milestones while protecting existing shareholders from dilutive effects? The answer is...debt, and CEO Robert Conway & Company are doing outstanding work not only stewarding the clinical and pre-clinical stage assets at Array but concurrently deploying a carefully architected fiduciary approach to the financing needs.

*NOTE* Feel the power of the Colorado BioScience Association (HERE)!
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Attention Thirsty Denver BioBeers Attendees!

2008-05-05T14:06:00.004-07:00

You may (or may not) know that the May edition of BioBeers will be held in Boulder. At the moment BioBeers, Inc. is in the process of securing BioBus transportation from Denver to Boulder and back. Please take a few minutes to indicate on the side-bar survey (left column on BioBeers.com if you are reading this in email or RSS reader) if you would i) be interested in the BioBeersBoulderBioBus and ii) if you would be willing to cough-up a few bucks for the round trip.

Kindly respond with your interest/preferences by Friday 9 May. Thank you.

More details (date/time/place) of May Boulder BioBeers to follow…

*NOTE* Feel the power of the Colorado BioScience Association (HERE)!
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It’s Starting to Look a lot Like BIO…

2008-05-05T07:29:00.004-07:00

The pre-event planning material for the BIO 2008 conference is pouring in fast and furious. (Do you plan to attend? Would you like to meet? Please contact me to arrange arubenstein@rnaventures.com). So whilst perusing the Product Focus Zone publication I was incredibly excited to see BaroFold (Boulder) highlighted in the Protein Therapeutics chapter. Jeff Cleland, Ph.D., VP of Therapeutic Development will be presenting BaroFold at this year’s BIO and was heavily quoted throughout the chapter highlighting the protein therapeutics market and in particular the proprietary PreEMT protein refolding technology that incorporates the use of high hydrostatic pressure to force water between protein molecules causing the dissociation of aggregates and thereby forcing the protein into its most compact form. Traditional aggregate removal techniques as part of the manufacturing process include chaotropic agents like guanidine hydrocholoride or urea to solubilize hydrophobic proteins which must then be removed. The PreEMT technology reduces the complexity of the manufacturing process and improves the quality of the protein therapeutic by increasing yield, homogeneity, stability and reducing production cost.

In other recent BaroFold news Mr. Jon Saxe, JD, LLM has joined the Board of Directors. Most recently Mr. Saxe was President of PDL Biopharma (NASDAQ: PDLI), then Protein Design Labs.

Finally, BaroFeron, a proprietary recombinant human interferon beta being developed for the treatment of Multiple Sclerosis, is expected to enter Phase I trials in 2H08. BaroFeron may be differentiated from other interferon-beta products by improved safety and greater bioavailability enabled by BaroFold's proprietary PreEMTTM technology.

It is exciting to see Colorado already shinning on the global BIO stage. Plenty more to come on BIO…

*NOTE* Feel the power of the Colorado BioScience Association (HERE)!
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Off to Phase IV for Letairis® and the Market for Volibris®

2008-05-02T08:01:00.002-07:00

Among the core assets that Gilead (Nasdaq: GILD) acquired from Myogen in 2006 for $2.5B was Letairis® (ambrisentan), for the treatment of pulmonary arterial hypertension (PAH), which was then approved by the FDA in mid 2007. After about a quarter in the market Gilead has initiated a Phase IV, randomized, double-blind, placebo-controlled study evaluating Letairis® in patients with PAH who have failed to demonstrate an optimal response to sildenafil monotherapy (Viagra® is not just for ED ya know…). The primary endpoint of this study, known as Athena-1, is the change from baseline in pulmonary vascular resistance (the resistance to blood flow caused by constricted lung blood vessels) following 24 weeks of treatment. The long-term safety and efficacy measures will be examined for up to one year. There are additional planned follow-on Phase IV studies through 2009.

Folks around town may recall that GlaxoSmithKline (NYSE: GSK) owns the rights to commercialize ambrisentan for PAH in territories outside of the US. Recently GSK announced that the European Commission issued a marketing authorization for ambrisentan, under the trade name Volibris®, for the treatment of PAH in patients to improve exercise capacity, and the European product launch is now scheduled for 3Q08. Very exciting global news that can trace its roots back to Colorado! Naturally we will be closely tracking performance of Letairis® and Volibris® in the coming months and years

*NOTE* Feel the power of the Colorado BioScience Association (HERE)!
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BioBootCamp 2008: Drop and Give Me 50!

2008-05-01T07:21:00.004-07:00

It is one week to go till BioBootCamp 2008 begins…are you ready to get your life-science start-up or start-up ideas in shape? Have you applied to attend? BioBootCamp is more than a 2-day business seminar, it is designed to help you jump start your new life science idea or company, this experience will provide you with not only a comprehensive overview of how to get your venture started, but will provide you exposure to experienced bioentrepreneurs and a nationally acclaimed faculty. By attending the BioBootCamp, you will learn how to avoid the legal pitfalls of starting and building a life science business, and will receive the assistance you may need to plan a solid foundation for your new business venture.

If you are interested in joining the growing numbers of Colorado life scientists eager to commercialize their ideas, click (here) for details on how to apply for this unique event (or copy/paste this link http://www.biobootcamp.com/apply.htm). This is a complimentary conference and there is no fee to apply or attend.

When: Thursday 8 May 7:30am – 5:00pm and Friday 9 May 7:30am – 2:00pm
Where: Holland & Hart 555 17th St. Suite 3200 Denver

*NOTE* Feel the power of the Colorado BioScience Association (HERE)!
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*NOTE* Read the new eBook CLSDF 2007 - What's In A Year? (HERE)!

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Insmed: Meeting Milestones!

2008-04-30T06:58:00.004-07:00

Insmed (Nasdaq: INSM) provided a status update on their development program.

After recently receiving approval form the UK Medicines and Healthcare Regulatory Agency to initiate a clinical trial for INS-19 [a follow-on biologic of Amgen’s (Nasdaq: AMGN) Neupogen®] patient screening has begun and the first dosing is expected next month with similarity data to be reported in June.

INS-20 [a follow-on biologic of Amgen’s (Nasdaq: AMGN) Neulasta®], Insmed’s second follow-on biologic candidate completed pre- clinical pharmacological and pharmacokinetic studies, and plans to initiate clinical studies 4Q08.

A Phase II study of IPLEX™, a complex of recombinant human insulin-like growth factor-I and its binding protein IGFBP-3, in Myotonic Muscular Dystrophy has been initiated and received IRB approval and is actively recruiting patients with enrollment north of 50% remains on target to complete enrollment in 1H08 with interim data analysis expected

Bard Center Needs Your Help!

2008-04-30T06:53:00.004-07:00

Two MBA students at the University of Colorado, Bard Center for Entrepreneurship are examining how their institution may better support the Colorado life science ecosystem via the delivery of specifically tailored graduate degrees, certificates and continuing education offerings that may ultimately empower, improve and expand the local workforce.

Kindly set aside five minutes of your time to complete their survey (HERE) or copy and paste this link in your browser: http://www.surveymonkey.com/s.aspx?sm=095p4OMPQQCjTWJJ_2ba3oTg_3d_3d.

The survey is confidential though you may add your email address at the end to request the final results. Your opinions are important! Thank you for time.

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Help Wanted: CU Technology Transfer Office

2008-04-29T07:14:00.002-07:00

The Technology Transfer Office at the University of Colorado is seeking an entry-level Life Sciences Licensing Associate for its office at the Anschutz Medical Campus. The License Associate identifies, solicits, and evaluates invention disclosures for patent and market potential, and marketing technologies to commercial partners and tracks and develops a portfolio of associated intellectual property. The License Associate will also ensure all assigned new invention disclosures are properly evaluated for ownership, patentability, and commercial viability; reasonably exercising professional, independent judgment in the selection and use of techniques, methods, and timing of decisions to complete all assigned responsibilities.

For a full job description, including minimum and preferred qualifications, please visit the Jobs at CU site (here).

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Evolutionary Genomics: Series A Undisclosed

2008-04-27T20:00:00.005-07:00

Evolutionary Genomics (Lafayette) an agricultural technology company who addresses the critical need to increase the availability of biofuel feedstocks has closed an undisclosed Series A financing with Denver-based Altira Group; not to be confused with the Altria Group or its much better known previous name Philip Morris (NYSE: MO).

EG’s Adapted Traits Platform is used to screen gene adaptations in biofuel feedstocks such as corn, switchgrass, sugar cane, algae and soybeans to improve yield-related traits, such as grains per plant, grain weight, yield per acre, biomass, drought resistance and disease resistance.

Altria Group focuses their fund thesis on the traditional and renewable energy sectors. The commitment to EG came from their $176M Fund V. Investments from this fund have typically been made in the $5-$10M range with follow-on investments as warranted.

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SBIR/STTR Bill Passes in House

2008-04-27T19:47:00.003-07:00

Lest you think the Colorado Bioscience Association merely flexes its muscle in Colorado…think again. Denise Brown and Company weighed in with significant support on Capital Hill re: HR5819 or the SBIR/STTR Reauthorization Act, which passed in the U.S. House of Representatives by a vote of 369 to 43.

All Colorado Representatives (Diana DeGette, Mark Udall, John Salazar, Marilyn Musgrave, Doug Lamborn and Ed Perlmutter) sans Tom Tancredo voted for the bill. Next stop is the US Senate.

HR5819 modifies the eligibility rules affecting venture capital backed (biotech) companies. The bill will increase access to critical, early-stage sources of funding for small businesses, including small biotechnology firms, thereby facilitating economic growth, job creation, and most importantly new breakthrough therapies for patients in need. Venture Capital and SBIR dollars may now work in a complementary manner to bring new therapies and innovations to the marketplace, ultimately to benefit patients and consumers. Potential great news for Colorado and the entire industry! We'll certainly pay close attention to the bill's progress.

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HB1001: A Bill Becomes Law! Hooray!!!

2008-04-24T13:48:00.004-07:00

It has been quite a journey for House Bill 08-1001 and today was graduation day; the Bill became law with the stroke of Governor Ritter’s pen!!! HB08-1001 a $26.5M package, sponsored by Rep. Jim Riesberg, (D-Greeley), and Sen. Bob Bacon, (D-Fort Collins), provides grants for five years to Colorado start-up companies and research institutions seeking to commercialize new biotech drugs, biofuels, medical devices and nanotechnologies. The grants are capped at $150,000 for research institutions and $250,000 for companies.

Tom Cech, Ph.D. who is stepping down from his post as President of the Howard Hughes Medical Institute to return to Colorado was on hand for the signing ceremony and provided some very encouraging words about the future of Colorado life science. There are no misperceptions here, Colorado is not yet on par with San Fran, Boston and San Diego…yet however, the passing of HB08-1001 will certainly aid in accelerating the development of the State’s life science intellectual property and place it squarely on the commercialization trajectory.

Many many thanks should also be extended to the amazing work done by Denise Brown and the entire team at the Colorado BioScience Association. Be sure to let them know how much their behind-the-scenes efforts are appreciated, perhaps at the next CBSA BioBreakfast to be held 30 April 7:30am at the Denver Museum of Nature and Science.

Looking forward next to reporting on how and who these critical dollars will be deployed to. Stay tuned…more info to come.

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Replidyne Terminates Trial Enrollment to Preserve Cash

2008-04-23T07:50:00.004-07:00

It is never a good feeling to wake up and hear that a pivotal late-stage clinical trial has terminated enrollment. However, there is a silver lining in such a difficult decision cloud…that is the sophisticated management at Replidyne (NASDAQ: RDYN) are savvy enough to examine the risk-reward profile for the continued burn of their remaining $78M cash position.

The Acute Exacerbation of Chronic Bronchitis study that has been halted is one in a package of four clinical trials, including two in community-acquired pneumonia and one in acute bacterial sinusitis, recommended as a way forward by the FDA for a new drug application submission for faropenem to treat these three adult community respiratory tract infections. Replidyne has not initiated the other three trials, and consistent with prior guidance, further faropenem development will depend on the securing a partner for the program.

Replidyne is required to conserve its cash position in order to maintain their array of research programs and to pursue strategic transactions. With cash in hand their remains an opportunity to advance the variety of additional pipeline assets such as the Clostridium difficile, DNA replication inhibition and pediatric faropenem programs. It is likely that there are meaningful value inflection points that may be achieved with these programs versus the obvious value previously demonstrated via the data from the previous nine Phase III and 3,000 patients enrolled in prior faropenem trials.

In fact, in my humble opinion, there appears to be so much value in Replidyne today that I am prepared to deviate a bit from my standard CLSDF protocol and make a prediction here…The oral community antibiotic market is very large and lucrative, with an average of 250 million prescriptions and sales of $7.5 billion per year over the last eight years. So rather than a seeking a partner deal, similar to what was disrupted with Forest Labs (NYSE: FRX), I predict a 2008 M&A transaction, and because of the program platform and the continued focus there that a big pharma deal north of $1B is in the works. Potential suitors may be GlaxoSmithKline (NYSE: GSK) via augmentin®, Pfizer (NYSE: PFE) via zithromax®, Ortho-McNeil via levaquin® or Abbott (NYSE: ABT) via omnicef®, just to name a few potential suitors. We shall see what happens…

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Allos: Completes Phase II PDX Study Enrollment

2008-04-22T07:03:00.002-07:00

Allos Therapeutics (NASDAQ: ALTH) has completed patient enrollment a quarter ahead of schedule for their Phase II trial of PDX (pralatrexate) in patients with relapsed or refractory peripheral T-cell lymphoma (PTCL).The pivotal Phase II trial is an international, multi-center, open-label, single-arm study that enrolled patients with relapsed or refractory PTCL who progressed after at least one prior treatment. Patients receive 30 mg/m2 of PDX once every week for six weeks followed by one week of rest per cycle of treatment, the treatment regimen also includes vitamin B12 and folic acid supplementation. The primary endpoint of the study is objective response rate (complete and partial response), secondary endpoints include duration of response, progression-free survival and overall survival.

The FDA granted orphan drug designation and fast track designation to PDX for the treatment of PTCL patients, and likewise the Committee for Orphan Medicinal Products of the European Medicines Agency granted orphan medicinal product designation to PDX.

Peripheral T-cell lymphomas, or PTCLs, are a biologically diverse group of blood cancers that account for approximately 10% to 15% of all cases of non-Hodgkin's lymphoma in the US. There are currently no pharmaceutical agents approved for use in the treatment of either first-line or relapsed or refractory PTCL. Patients are often treated with multi-agent chemotherapy regimens however, a significant number of these patients relapse or become refractory after treatment with first-line therapy. The average five-year survival for those patients was approximately 25%.

PDX is a novel, small molecule chemotherapeutic agent that inhibits dihydrofolate reductase, or DHFR, a folic acid (folate)-dependent enzyme involved in the building of nucleic acid, or DNA, and other processes. PDX was rationally designed for efficient transport into tumor cells via the reduced folate carrier, or RFC-1, and effective intracellular drug retention. Allos believes these biochemical features, together with preclinical and clinical data in a variety of tumors, suggest that PDX may have a favorable safety and efficacy profile relative to methotrexate and other related DHFR inhibitors and, has the potential to be delivered as a single agent or in combination therapy regimens.

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BioBeers Next Meeting: 29 April 6:00pm

2008-04-20T19:42:00.008-07:00

BioBeers is locked and loaded for Tuesday 29 April at our new start time of 6:00pm, enabling even more networking time over the malts and hops; BioBeers is working overtime for you! Now there has been some debate about where to hold this months’ BioBeers, so we elected to settle the question the democratic way by asking you all to vote early and vote often on BioBeers.com. The finally tally...

Denver 35
Boulder 18
Ft. Collins 11
Colorado Springs 0

Those sentient to the barley and yeast flowing along Pearl St. may be familiar with the Mountain Sun or perhaps the Colorado Kind Java Porter served up at the Sun’s SOBO cousin, the Southern Sun. Well despite Denver tallying the most votes, we are efforting to bring a little taste of Boulder to Denver by meeting at the recently opened Vine Street Pub (which completes the Mountain Sun family trifecta).

Now don’t lose faith all ye Bio-Boulderites...for the BioBeers May edition will be packing its bags and heading north to be held somewhere in the shadow of the Flatirons next month, so sit tight. Your suggestions for fav locale are welcome!

When: Tuesday 29 April 6:00pm
Where: Vine St. Pub, 1700 Vine St. Denver 80206

As always please kindly RSVP with the click of a mouse at BioBeers.com. Thanks and see you soon for a cold one…

"Fermentation and civilization are inseparable." John Ciardi (1916-1986)

Insmed Gets First FOB Clinical Study Greenlight!

2008-04-18T07:14:00.002-07:00

An important milestone for Insmed (NASDAQ: INSM), developer of follow-on biologics and biopharmaceuticals, was achieved in the form of approval from the UK's Medicines and Healthcare products Regulatory Agency to initiate their first clinical study for INS-19, a follow-on biologic product candidate. INS-19, is a recombinant form of human G-CSF, is a follow-on biologic of Neupogen®. Amgen (NASDAQ: AMGN) booked 2007 sales of Neupogen® that approached $900M, and the patent expires in 2013.

The Phase I study will be conducted in the UK and will compare the safety and establish the bioequivalence of INS-19 to Neupogen®. Results from the trial are expected in 2H08, and are planned to be used as part of a submission to the FDA to establish a protocol with the agency for a Phase III trial in the U.S.

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Corgenix: Approval for IgG Anti-AtherOx® Dx Test

2008-04-17T07:30:00.003-07:00

Corgenix Medical Corporation (NASDAQ: CONX.OB) received 510(k) clearance by the FDA for their IgG Anti-AtherOx® Test Kit. This new laboratory test detects antibodies in individuals with important autoimmune diseases such as systemic lupus erythematosus and other and lupus-like disorders.

The AtherOx® technology utilizes oxidized low-density-lipoprotein (oxLDL) complexed with the plasma protein B2GPI. Although oxLDL has been implicated in cardiovascular disease, according to results published in the Annals of N.Y. Academy of Science (2007), determination of oxLDL/B2GPI complexes, rather than oxLDL alone, may be a more physiologic and accurate way of assessing the risk of progressive atherosclerotic cardiovascular disease in individuals with systemic lupus erythematosus and lupus-like disorders. Corgenix licensed this technology in 2002, and is developing additional products utilizing this unique platform. Two U.S. patents have been issued and several others are pending.

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Accelr8 and Becton Dickinson Agree to Terms

2008-04-17T07:15:00.005-07:00

Accelr8 Technology Corporation (AMEX:AXK) announced an agreement with Becton, Dickinson (NYSE: BDX) for the BACcel™ rapid bacterial diagnostic system. Becton will fund an 18-month milestone-based project which includes the option to license the technology for product development, manufacturing and, commercialization use for the clinical diagnosis of infectious diseases. BACcel™ rapid diagnostic system may deliver bacterial identification and specific antibiotic susceptibility testing within 8 hours of specimen receipt by eliminating culturing and is based on innovative surface coatings, assay processing, and detection technologies.

Additional good news includes the issuance of Accelr8’s core Quantum Microbiology™ patent and, the acceptance of three scientific presentations for the 108th General Meeting of the American Society for Microbiology, 1-5 June, Boston. Subjects to be covered include multiplexed identification of multiple drug resistance mechanisms, rapid Acinetobacter immunoassay performance, and quantitative analysis of bacteria extracted directly from human clinical specimens.

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Biz-Plan Competition Feedback

2008-04-16T08:10:00.002-07:00

Friends Maggie Popesco, Ph.D. and Eric Hoffman, MS are students at the University of Colorado Denver Business School and have entered the Bard Center for Entrepreneurship Business Plan Competition. They are developing a business plan around a company (Evolve Biosciences) which will target non-therapeutic biotechnology, medical device, and diagnostic IP developed at Colorado universities. Currently, they are working with the technology transfer office at National Jewish Medical & Research Center to develop a knee aspirate facilitating device. Results from this survey will assist them in developing the market analysis section of their business plan.

Any relevant feedback would be most appreciated in addition to passing the survey along to appropriate friends and colleagues. Click (here) to download or copy and paste the following link: http://ab.rubenstein.googlepages.com/kneeaspiratedevicesurvey. Thank you for supporting the entrepreneurial process, it is the collegial, supportive and nurturing environment that makes Colorado bioscience a special place and a special time.

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Lanx: Series A $25M

2008-04-15T09:51:00.005-07:00

Lanx (Broomfield) a medical device company developing and marketing surgical implants and biological products for spinal surgery closed a $25M Series A financing led by Chicago Growth Partners and also included co-investors Goldman Sachs and Oakwood Medical Investors.

The Company currently markets 15 product lines of implants and associated instrumentation for spinal fusion surgery. Lanx is also aggressively developing additional product lines in its core fusion market as well as a broad platform of products in the emerging non-fusion and orthobiologics markets.

This is an incredibly exciting financing for Colorado, there are no Colorado institutional investors participating in this round, top-tier capital attraction came from Chicago, New York and St. Louis.

*NOTE* Feel the power of the Colorado BioScience Association (HERE)!
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Amgen: Denosumab, Part III

2008-04-11T07:23:00.003-07:00

CLSDF has been paying particular attention to the clinical development of Amgen’s (NASDAQ: AMGN) Denosumab, a monoclonal antibody that targets RANK Ligand, the essential mediator of osteoclasts - the cells that break down bone (Read Part I HERE and Part II HERE). Now, pivotal Phase III data shows Denosumab increased bone density at multiple skeletal sites in early and later-stage postmenopausal women.

Results from a 24-month, 332-patient Phase III pivotal study in women with early and late-stage postmenopausal osteoporosis was published in the Journal of Clinical Endocrinology and Metabolism. In this study, twice-yearly subcutaneous injections of Denosumab increased bone mineral density (BMD) at all sites measured, including in highly cortical areas of the skeleton. Cortical bone comprises 75 percent of skeletal mass and is a primary determinant of overall strength in vertebral and non-vertebral sites throughout the skeleton. Denosumab treatment significantly increased lumbar spine BMD compared with placebo and also produced significant increases in BMD at the hip, wrist, and total body.

Amgen expects the results of its large, pivotal Phase III registrational study, which will evaluate Denosumab's impact on fracture risk reduction, in women with postmenopausal osteoporosis, in the 2H08.

Next week we should have an update on Amgen’s oncology pipeline of five investigational compounds AMG 102 (a fully human monoclonal antibody that targets the action of hepatocyte growth factor/scatter factor), 386 (a recombinant Fc-peptide fusion protein (peptibody) targeting angiopoietins), 479 (a fully human monoclonal antibody that binds to insulin-like growth factor-1 receptor without cross-reacting with the closely related insulin receptor), 665 (a fully human monoclonal antibody agonist directed against Death Receptor 5) and 706 (Motesanib diphosphate is a highly selective, oral agent that is being evaluated for its ability to inhibit angiogenesis and lymphangiogenesis by targeting vascular endothelial growth factor receptors 1, 2 and 3).

*NOTE* Feel the power of the Colorado BioScience Association (HERE)!
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AspenBio Pharma and Novartis Ink License Deal

2008-04-10T07:19:00.004-07:00

AspenBio Pharma (NASDAQ: APPY) entered into a license agreement with Novartis Animal Health (NYSE: NVS) for the world-wide rights for the development and launch of AspenBio's novel recombinant single-chain bovine products, BoviPure LH™ and BoviPure FSH™. The license agreement is generally for the term of the patents and the arrangement provides for a sharing of product development, costs and worldwide product sales. AspenBio receives an upfront cash payment and ongoing royalties based upon net direct product margins as and has agreed to share in 35% of the product development and registration costs.

BoviPure FSH is a novel single chain follicle stimulating hormone analog for cows with many potential advantages over existing products. BoviPure LH is a novel single-chain luteinizing hormone (LH) analog for cows. This new bovine LH hormone analog is the first of its type in the world and is designed to increase pregnancy rates in dairy cows using both pre-breeding and post-breeding applications.

If you have a few moments be certain to watch this NASDAQ CEO Signature Series broadcast featuring Richard G. Donnelly, President and CEO of AspenBio Pharma. Click (HERE) to watch.

AspenBio Pharma is an emerging bio-pharmaceutical company dedicated to the discovery; development, manufacture, and marketing of novel proprietary products, including those that enhance the reproductive efficiency of animals and that have large worldwide market potential. The company was originally formed to produce purified proteins for diagnostic applications and has become a leading supplier of human hormones to many of the nation's largest medical diagnostic companies and research institutions. The company has successfully leveraged this foundational science and technology expertise to rapidly develop an enviable late-stage pipeline of several novel reproduction hormone analogs for wide-ranging therapeutic use in animals of economic importance. AspenBio Pharma continues to advance the development and testing of its two first-generation blood-based human diagnostic tests designed to rapidly help diagnose or rule out acute appendicitis in patients complaining of abdominal pain.

Ceragenix: $1.5M Milestone Payment from Dr. Reddy’s

2008-04-09T07:06:00.003-07:00

Denver-based Ceragenix Pharmaceuticals (NASDAQ: CGXP.OB) a biopharmaceutical and medical device company focused on infectious disease and dermatology, announced that it received a $1.5M milestone payment pursuant to its exclusive distribution and supply agreement with Dr. Reddy’s Laboratories (NYSE: RDY), for the commercialization of EpiCeram®.

Ceragenix has two base technology platforms - Ceragenins™ for treatment of infectious disease and Barrier Repair for the treatment of dermatological disorders including atopic dermatitis, neonatal skin disorders and others. Ceragenin™ compounds are active against a broad range of gram positive and negative bacteria and has been used formulate Cerashield™ antimicrobial coatings for medical devices. The Company’s patented Barrier Repair technology is the platform for the development of two prescription topical creams - EpiCeram® and NeoCeram™. EpiCeram® has been cleared for marketing by the FDA and the Company has entered into an exclusive agreement with Dr. Reddy’s for marketing and sales in the US. Ceragenix anticipates that Dr. Reddy's will launch EpiCeram® during 2H08! That would be fantastic!

Quark Pharma: Lands $27M, Expands Clinical Programs

2008-04-08T07:46:00.003-07:00

Back in February CLSDF highlighted Quark Pharmaceuticals as another private company headquartered outside of Colorado yet with a major presence in Colorado. The company announced the close of a $27M financing led by SBI Asset Management which may enable drug candidates in five clinical programs by 2H08. As a result of the financing clinical operations in the Boulder office is expected to ramp. It already appears as though hiring in the office is underway (here) with more expected. Great news for Quark, for Boulder and for the continued advancement of siRNA technologies.

If anyone from Quark is reading this be certain to post your openings on the BioBeers job board (http://BioBeers.com)

Quark has a robust product portfolio including two clinical, one pre-IND and six pre-clinical candidates in development. Its lead product candidates are RTP801i-14, an siRNA molecule in Phase I/IIa clinical trial for the treatment of wet age-related macular degeneration that is licensed to Pfizer on an exclusive worldwide basis. AKIi-5, a Phase I, siRNA molecule for the prevention of acute kidney injury and acute renal failure following major cardiac surgery, and AHLi-11, a pre-IND siRNA molecule for the prevention of chemotherapy and noise-induced hearing loss.

*NOTE* Feel the power of the Colorado BioScience Association (HERE)!
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HB08-1001 Achieves Another Major Milestone!

2008-04-08T07:13:00.002-07:00

It has been about a week since we last checked in on the progress of HB1001, yesterday the Colorado Bioscience bill that will inject over $26M into our ecosystem over the next five-years PASSED in the Senate!!! How exciting!!! Next stop for the legislation is to go back to the House for a final vote on the wording of the amendments made since its 27 February approval…

Here is a snapshot of HB1001’s journey to date:

01/09 Introduced In House Assigned to Finance + Appropriations
01/30 House Cmte on Finance Refer Amended to Appropriations
02/22 House Cmte on Appropriations Pass Amended
02/26 House Second Reading Passed with Amendments
02/27 House Third Reading Passed
03/03 Introduced In Senate
03/11 Senate Cmte on Biz, Labor and Tech Refer Amended to Finance
03/18 Senate Cmte on Finance Refer Unamended to Appropriations
03/28 Senate Cmte on Appropriations Pass Unamended
04/03/ Senate Second Reading Laid Over
04/04 Senate Second Reading Passed with Amendments
04/07 Senate Third Reading Passed with Amendments

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What’s Your Pre-Money Valuation?

2008-04-05T17:26:00.003-07:00

Setting a pre-money valuation is always an interesting step in the funding process. I’ve seen potential deals quickly unwind as a result of an entrepreneur standing firm on an irrationally perceived valuation, or an unsophisticated angel investor(s) setting a seed round price that is misaligned with the venture community. It is always a terrible shame when this occurs. In the video below Jason Green of Emergence Capital Partners speaks to what he believes as one of the biggest mistakes made by entrepreneurs, that is, responding to the loaded valuation question (If you are reading this post as an email or in your RSS aggregator click HERE to view the video).

*NOTE* Feel the power of the Colorado BioScience Association (HERE)!
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Fastest Growing Regions for Venture Capital

2008-04-04T07:40:00.005-07:00

The National Venture Capital Association released some interesting data highlighting the five fastest growing regions for attracting venture capital outside of Silicon Valley and New England. The analysis focused on the ten-year growth rates for regions across the country and ranked the fastest growing areas based upon the number of companies funded, excluding areas that had under $100M in investment in 2007. Mind you, this data is not simply life science deals but total venture deals across all sectors of investing. In 2007 Colorado attracted a total of $564M in 86 total deals, across all sectors of investing (this was off nearly $10M from 2006). So though CO does not appear on this new hot growth regions for attracting capital list it may very likely be due to the fact that in excess of $1B in venture dollars was attracted to the State from 2006-2007; OK, my feelings are not hurt. On to the data…

2007 No. CO’s Total Invest 1997 No. CO’s. Total Invest
New Mexico 21 128.2M 3 27.0M
Pittsburgh 44 198.2M 12 32.3M
Seattle 132 1253.4M 65 403.2M
Los Angeles 124 1146.0M 73 459.3M
Washington DC 180 1282.1M 105 558.2M

The most active investors in these five regions include: Verge Fund, Flywheel Ventures, EPIC Ventures, Innovation Works, Draper Triangle, Pittsburgh Life Science Greenhouse, Novitas Capital (not Novartis), Ignition Partners, Madrona Venture Capital, OVP, Clearstone Venture Partners, US Venture Partners, Draper Fisher Jurvetson, Redpoint Ventures, Novak Biddle Venture Partners, Columbia Capital, Grotech, New Enterprise Associates and Valhalla Partners.

*NOTE* Feel the power of the Colorado BioScience Association (HERE)!
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Replidyne: Reading Between the Retention Lines

2008-04-03T07:11:00.003-07:00

It is no secret that Replidyne (NASDAQ: RDYN) is highly focused upon architecting and executing a new strategic alliance, to replace the Forest Labs (NYSE: FRX) deal that unwound, in order to shepherd the commercialization efforts of Faropenem.

A form 8K was filed with the SEC by the Louisville headquarters announcing a retention bonus has been put into effect with the Sr. VP of Corporate Development and the Chief Financial Officer. No need to name names and numbers here as that is easily identified by those who wish to seek out the info, no, what interests me more is the date of 30 September 2008 as the trigger date for the bonuses as well as the definitions of such an alliance whereby:

(i) a strategic alliance or partnership with an unaffiliated third party that relates to the development and commercialization of faropenem medoxomil or (ii) another strategic transaction to which the Company is a party. The term of the Retention Bonus Agreements extends until the later to occur of (i) September 30, 2008 and (ii) ten days following the consummation of a strategic transaction, provided that the Company has made all required payments thereunder.

So I reckon that there are a couple of ways one can read between the lines of this retention program. At this moment I’ll elect the very bullish angle that a deal may be in the works and will be done by 3Q08, fingers crossed!

*NOTE* Feel the power of the Colorado BioScience Association (HERE)!
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Thom Cech, Ph.D.: Sweet Home Colorado!

2008-04-02T20:42:00.002-07:00

Thom Cech who has been serving as the President of the Howard Hughes Medical Institute (HHMI) since 2000 announced that he will be stepping down in the spring of 2009 and returning to Colorado. Dr. Cech plans to resume his position as an HHMI investigator at the University of Colorado, where he has been a faculty member since 1978. In 1989 Dr. Cech won the Nobel Prize in Chemistry with Sidney Altman of Yale University (who just happened to have received his Ph.D. from the University Colorado in 1967) for their discoveries that illuminated the catalytic properties of RNA.

In 1982, Dr. Cech and his research group announced that an RNA molecule from Tetrahymena, a single-celled pond organism, cut and rejoined chemical bonds in the complete absence of proteins. And from what I understand the pond was adjacent to the quad on the Boulder campus where the Tetrahymena was fished out of. Below is an embedded satellite view of the famous pond courtesy of google maps - be sure to zoom in on it using the + in the upper-left, located between University Ave. and Pleasant St. (if you are reading this as an email or in your RSS reader you will have to pop over to the site http://CLSDF.com to see the famous pond). This discovery of self-splicing RNA provided the first exception to the long-held belief that biological reactions are always catalyzed by proteins.

It is exciting news for the entire Colorado life science eco-system to have Dr. Cech return home. Stay tuned for more detail on planned activities…

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Denver BioVentures Closes $425M Fund I

2008-04-01T09:04:00.003-07:00

Denver BioVentures emerged from stealth mode (though still no website) to announce the close of DBV Fund I, the rather impressively sized initial fund closed at $425M with their sights set exclusively on Colorado Bio. Patricia Tsanos, Ph.D., MBA who left Boston-based Adhesion Capital Partners last year wanted to spend more time at her 16,000 square foot Aspen vacation home, and thus founded Denver BioVentures dropping their shiny new uber-modern office right in the middle of Pearl St. in downtown Boulder. I guess you can say she earned some R&R time after she 10X’d or better all seven of her Adhesion Cap Partners Fund III bio investments, returning in excess of $17 billion to her limited partners. Word on the street courtesy of Venture Industry Monthly is that Pat walked away with a cool $875M in less than six years. That is over $71,000 per hour…what can you say…

Hopefully Dr. Tsanos brings more of her magic investing touch to Colorado. It was via the discovery of CLSDF while Dr. Tsanos was engaged in some early diligence of Colorado bio deal flow last summer that I had the opportunity to meet and actually spend some time with her, first at her palatial Aspen 52-acre compound that she continued to refer to as her “country shack”. It was quite an experience evening getting there as Dr. Tsanos insisted that her luxurious Augusta 109 executive helicopter (the same one used to shuttle guests around at the six star Burj Al Arab hotel in Dubai) dropped down out of the sky to touch down in the grassy knoll adjacent to the parking lot of the Colorado Science + Technology Park @ Fitzsimons headquarters. Thirty turbo-prop minutes later I am in Aspen airport being picked up in what I was soon to find out is one of only six produced in the world 100% electric Rolls Royce Phantom Drophead Coupe’s, which I soon found out priced at $620K and was lovingly referred to throughout the weekend as the “convertible”. Despite the opulent wealth and eccentricities of Dr. Tsanos, e.g. while dining at the world famous Nobu Matsuhisa in downtown Aspen for Friday night dinner she de-plated her lobster ceviche with lime stone lettuce and launched it at the unsuspecting sushi chef proclaiming that it was not Maine lobster she was tasting. Similar outbursts were a common occurrence throughout the weekend.

For some absurd reason Denver BioVentures three Managing Directors, two of which can not be named publicly by me according to the non-disclosure agreement I was ‘coaxed’ into signing have elected, at least for the time being, to communicate publicly solely via CLSDF. And in the spirit of full disclosure I have absolutely no financial ties to the new fund, though I was informed if I provide a days notice I can use the Augusta 109. So with that said the following comes forth from Dr. Patricia Tsanos:

My fund thesis is to leverage implicit irrational drug design
I am only interested in working with male/female scientific-founder pairs
If you question the pre-money valuation I set then get out of my office…IMMEDIATELY!
Contact Alan if you wish for me to review your business plan*

Yes, Dr. Tsanos despite how ever many times I have corrected her has decided that I look more like and Alan then an Adam. What can I say? So if you are an “implicit irrational drug designer” are part of a “male/female” scientific founding team and will not question a pre-money valuation set by Dr. Tsanos and the rest of the Denver BioVenture partners send me an email or leave a note below in the comment section and we can arrange for a meeting. Thank you.

HAPPY APRIL FOOLS DAY!